What Happens When You Mishandle 129,000 Customer Complaints?
May 29th, 2025 // 7:57 pm @ jmpickett
Mishandling thousands of customer complaints is always bad. When you make medical devices for the US market, it’s worse. We came across a 2018 FDA 483 for Philips Medical System in Cleveland. The firm was slammed by FDA for inadequate handling of more than 129,000 complaints.
FDA investigators visited Philips Medical System in 2017 and discovered huge issues with how it addressed 133,845 medical device complaints. The FDA inspectors found that 129,736 complaints were closed based on just the assigned hazard/harm symptom code. They were not investigated.
This terrible complaint handling system was used at the Cleveland facility, despite discrepancies between symptom codes assigned and the highest risk matrix severity level of possible severe injury or death in at least 3,600 complaints. At least 1790 of those high-risk complaints should have been investigated. Just 49% of the 104 serious harm complaints were investigated.
Of the large batch of customer complaints, 68% involved table problems. Several complaints said the same problems happened ever month or several times per year. However, Philips Medical System closed the complaints, failing to take necessary corrective actions. Nor did it submit adverse event reports to the agency.
Complaint Handling System Was Inadequate, FDA Said
The company’s complaint handling procedures were subpar because they didn’t have a descripton of how and when failure codes are provided during the complaint protocol. This error led to 129,736 complaints missing vital codes needed for data analysis and to decide if further actions were warranted.
Other serious complaint handling non-conformities found during the FDA inspection included three repeat 483 observations from a 2014 inspection related to lack of procedures for CAPAs. For example, a CAPA that was started to address software problem escapes was closed without the root cause investigation.
How To Handle Complaints Effectively and Compliantly?
FDA investigators consider how a medical device company handles complaints to be a critical indicator of a manufacturer’s overall state of control of their Quality System. If the complaint and MDR
systems are not in a “state of control,” odds are the rest of the quality system is out of compliance. Inadequate complaint handling procedures are a common FDA 483 and warning letter observation.
Ensuring your firm has compliant complaint handling processes per 21 CFR Part 820.198 means:
- Establishing a clear written procedure to comply with the regulation. Determine what a ‘complaint’ is. Generally, a complaint about a medical device is any written, electronic, or oral communication alleging deficiencies in a device’s identity, quality, durability, reliability, safety, effectiveness, or performance.
- Name a complaint handling team/unit. You must assign a team to manage complaints. Make sure team personnel understand FDA regulations for medical devices and how complaints must be handled.
- Implement a strong complaint intake system. You should create easy-to-access channels to receive customer complaints, such as a dedicated phone number, website, email address, or customer service team. Every complaint must be recorded with date, details, device information, and type of issue. Use a standard form to capture data consisently.
- Review and evaluate complaints promptly to decide if an investigation is needed. Then assess if the complaint involves a possible device failure, or if it’s labeling or packaging. Categorize the complaints to address severity and how quickly to handle them.
- Investigate complaints for device failures, safety problems, and specification non-compliance.
- Determiner MDR requirements. Study if the complaint requires an MDR per 21 CFR Part 803. MDRs must be sent to FDA within 30 days of the event. Maintain an MDR record, even if you don’t file a report.
- Integrate with CAPAs to pinpoint trends or systematic problems. Document the CAPAs that relate to specific complaints.
- Train your staff. You need to ahve regular training for handling complaints, as well as on FDA regulations and MDR requirements.
- Be ready for FDA inspections: Keep your complaint files complete, accurate, and easily accessible.
A med device company can keep an FDA-complaint process for handling complaints by following these steps.
