LITHIUM ION BATTERIES - QTY 2 90522

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-05-20 for LITHIUM ION BATTERIES - QTY 2 90522 manufactured by Integra York, Pa Inc..

Event Text Entries

[45587210] To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10


[45587211] Customer initially reports that the battery was getting hot inside holster on surgeons hip. On (b)(6) 2016 customer reports that doctor was performing a spinal fusion when he felt the battery was hot, after one hour of use.. Battery was removed from holster. The heat burned a hole in the battery. No harm to the doctor. #1 of 2 related complaints.
Patient Sequence No: 1, Text Type: D, B5


[47926266] On 6/7/2016 integra investigation completed. Manufacture date unknown method: failure analysis, device history evaluation, results: failure analysis - battery only received. Inserted battery into holster, connected to led headlight for 2 hours on highest setting. Run time temp was 81. 9f, which is not an abnormal temperature for a battery in use. Battery tests within specification. Complaint report is unconfirmed. Device history evaluation - nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: none. Engineering change order / manufacturing change order history: none. Corrective action preventive action history: none. Health hazard evaluation history: none. Conclusion: the report of battery getting hot inside holster could not be confirmed. After the evaluation of the returned sample, it was found that the battery could power a headlight and not over-heat in holster. The complaint report is unconfirmed; testing within specifications.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2523190-2016-00070
MDR Report Key5669471
Report SourceUSER FACILITY
Date Received2016-05-20
Date of Report2016-05-06
Date of Event2016-05-04
Date Mfgr Received2016-06-07
Date Added to Maude2016-05-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactUSER SANDRA LEE
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1INTEGRA YORK, PA INC.
Manufacturer Street589 DAVIES DRIVE
Manufacturer CityYORK PA 17402
Manufacturer CountryUS
Manufacturer Postal Code17402
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLITHIUM ION BATTERIES - QTY 2
Generic NameLIGHTING
Product CodeFSR
Date Received2016-05-20
Returned To Mfg2016-05-19
Catalog Number90522
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA YORK, PA INC.
Manufacturer Address589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402


Patients

Patient NumberTreatmentOutcomeDate
10 2016-05-20

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