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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DUO LITHIUM ION BATTERIES - QUANTITY TWO; PFM05
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DUO LITHIUM ION BATTERIES - QUANTITY TWO; PFM05 Back to Search Results
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 1 of 3 reports which are linked to mfg report numbers: 2523190-2020-00151; 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 shows no abnormalities related to the reported issue.The duo lithium ion batteries were returned for evaluation: failure analysis: the investigation of the returned device showed that on visual inspection the returned battery was in used condition with residue on the outside and physical damage to the edges.Root cause: the reported complaint is confirmed from the evaluation.Batteries are in used condition with physical damage as well as residue, indicating battery leakage.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.
 
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Brand Name
DUO LITHIUM ION BATTERIES - QUANTITY TWO
Type of Device
PFM05
MDR Report Key10983315
MDR Text Key220778887
Report Number2523190-2020-00150
Device Sequence Number1
Product Code FSR
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 Number90622
Device Lot Number1918
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2020
Initial Date Manufacturer Received 11/19/2020
Initial Date FDA Received12/10/2020
Supplement Dates Manufacturer Received12/09/2020
Supplement Dates FDA Received12/31/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/02/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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