MAUDE Adverse Event Report: DUO LITHIUM ION BATTERIES - QUANTITY TWO; PFM05

Catalog Number 90622

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

This is 2 of 3 reports which are linked to mfg report numbers: 2523190-2020-00150, 2523190-2020-00152.A facility reported that while the surgeon was using the headlight during a spinal case, the duo lithium ion battery (1 of 2 batteries) began to get hot on his hip.It was taken off and there was liquid coming from the battery.The holster knob was also coming off and was being held on with tape.There was no patient injury and the surgeon's condition was fine.There was a delay in surgery of 1 to 3 minutes to change the batteries.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).Device history record (dhr) - dhr was reviewed and no abnormalities related to the reported issue were observed.Failure analysis: visual inspection showed that the returned battery was in used condition with physical damage, but functioning normally and with no indication of leakage.Battery functioned properly when used with a 90600 headlight.Root cause: the reported complaint is not confirmed.Battery had physical damage, but functioned normally and had no indication of leakage.No manufacturing, workmanship, or material deficiency has been identified.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

N/a.

• Brand Name: DUO LITHIUM ION BATTERIES - QUANTITY TWO
• Type of Device: PFM05
• MDR Report Key: 10982937
• MDR Text Key: 220659573
• Report Number: 2523190-2020-00151
• Device Sequence Number: 1
• Product Code: FSR
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

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: 90622
• Device Lot Number: 2017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1