BATTERY CHARGER, SINGLE BAY
Received Jun 14, 2019
Report 2523190-2019-00082 · MDR key 8699811
Device
Product problems
- Device Emits Odor
- Overheating of Device
- Device Emits Odor
- Overheating of Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, THEREFORE THE FAILURE MODE CANNOT BE CONFIRMED. THE SERIAL/LOT NUMBER WAS NOT PROVIDED TO PERFORM DEVICE HISTORY RECORD REVIEW. FAILURE ANALYSIS AND DETERMINATION OF ROOT CAUSE IS NOT POSSIBLE DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED. THE REPORTED COMPLAINT IS UNCONFIRMED. DEVICE IDENTIFIER: (B)(4).
Additional Manufacturer Narrative
ADDITIONAL INFORMATION RECEIVED ON 26AUG2019 INDICATING THAT THERE WAS NO DELAY IN THE PROCEDURE DUE TO PRODUCT PROBLEM. THE CHARGER WAS NOT USED DURING SURGERY. AFTER THE PRODUCT PROBLEM OCCURRED, THEY STOPPED USING THE BATTERY CHARGER AND DISCARDED IT. NO PATIENT IMPACT OR ADVERSE CONSEQUENCE REPORTED.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
A REGULATORY AFFAIRS SENIOR SPECIALIST REPORTED ON BEHALF OF THE PHYSICIAN THAT THE 90523 BATTERY CHARGER, SINGLE BAY WAS OVERHEATING AND HAD A MELTING PLASTIC (BURNING SMELL). THE PRODUCT WAS DISCARDED BY THE CUSTOMER. THE EVENT DATE IS UNCLEAR. IT WAS UNKNOWN IF THERE WAS PATIENT CONTACT, OR A SURGERY DELAY, HOWEVER THERE WAS NO ADVERSE EVENT REPORTED. ADDITIONAL INFORMATION RECEIVED ON 11JUN2019 NOTED THAT THERE WAS NO MENTION OF THE PRESENCE OR ABSENCE OF SMOKE.