MAUDE Adverse Event Report: SYNTHES OBERDORF UNIVERSAL BATTERY CHARGER II; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 05.001.204

Device Problem Flare or Flash (2942)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported from (b)(6) that before surgery, it was observed that the blue led on the universal battery charger device was flashing.There were no delays in the surgical procedure.It was not reported if a spare device was available for use.There was no patient involvement.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The device was returned to the manufacturing site for further evaluation.Reliability engineering evaluated the device and found a malfunctioned electrical component (opto-coupler) inside the charger.It was determined that this led to the reported failure.Therefore, the reported condition was confirmed.It was determined that a blue led was flashing and the device failed self-test.The assignable root cause was determined to be due to faulty production and process error during manufacturing.This issue has been escalated to capa.Therefore, the reported condition was confirmed.If additional information should become available, a supplemental medwatch report will be sent accordingly.

• Brand Name: UNIVERSAL BATTERY CHARGER II
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5197484
• MDR Text Key: 30597868
• Report Number: 8030965-2015-11803
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2015
• Initial Date FDA Received: 11/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1