How to handle a customer complaint on a medical device

A complaint can come as a call, an email, a distributor’s note or a returned unit. Each gets the same entry. Record who complained, when you learned of it, the device name, the serial or lot number and what happened.

Do not wait to confirm the fault. Log it anyway. The log date starts the clock for any reporting duty you hold, so check your own regulator’s rules and keep that date firm.

The next step is a lookup. From the serial number, pull the device history record, the material lots, the inspection readings and any earlier service visits. Software turns this into one screen instead of a hunt through three cabinets.

Check who else holds units from the same lot. Software lists the distributors and hospitals in one query. If the fault might be systemic, you need that list early. Pull it before the investigation starts.

Someone qualified must judge whether the event meets your regulator’s threshold for a report. Record the decision, the reasoning and the person who made it. A decision of no report still needs a written reason.

Revisit the call when new facts arrive. A complaint that looked minor can change once the returned device is opened and examined on the bench.

Examine the returned unit if you have it. Compare it against the drawing revision it was built to. Check the lot, the operator, the machine and the inspection readings, and put photographs and measurements into the file.

Name a root cause or state plainly that none could be found. Both are acceptable. A blank is not acceptable. If the cause points at a process, open a corrective action linked to the complaint number.

Reviewers later look for the thread from symptom to cause to fix. Keep it intact. A file that jumps from a reported crack to a closed status, with no measurement in between, invites questions that nobody present can answer.

Close the complaint only when the reply to the customer is sent, the corrective action is verified and the file holds the evidence. Record the closing person and the date.

Then look across complaints. Trends hide in single files. Zoom out. The monthly sweep is where a quiet pattern, such as repeated ratchet slippage on one model, finally reaches someone with authority to act. Group them by device, lot and failure type every month. Three similar entries in a quarter make a trend, and a trend deserves its own review meeting with quality, production and service in the room.