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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH TRULED ADULT RECHARGEABLE BATTERY BATTERY, RECHARGEABLE

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TELEFLEX MEDICAL RUSCH TRULED ADULT RECHARGEABLE BATTERY BATTERY, RECHARGEABLE Back to Search Results
Catalog Number 0055502
Device Problem Battery Problem (2885)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 08/05/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Product usage when the alleged issue was detected is unknown. The device sample was not returned for evaluation at the time of this report.
 
Event Description
The customer alleges that the battery is either broken or has failed. No patient injury reported.
 
Manufacturer Narrative
(b)(4). A device history record (dhr) review was performed reviewed on the lot number of the sample received (1451v3) and no issue that could have contributed to the reported failure was noted. The device was manufactured according to release specification. The sample was returned for evaluation. The led would not energize upon receipt. The cartridge was connected to a known good charging unit (located on the charging end of the device). Immediately the cartridge went into a battery/circuitry fail mode with the red charging light flashing. The unit was completely disassembled for further investigation. There were no visual signs of corrosion on either end of the battery, to include the battery itself, soldered joints, and pcbs. Wires were firmly attached. After disconnecting pcb from both ends of the battery a voltage test revealed that the li-ion battery was almost fully charged at 3. 6 vdc. A conclusion code could not be chosen as the complaint was confirmed; however, a root cause was not established.
 
Event Description
The customer alleges that the battery is either broken or has failed. No patient injury reported.
 
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Brand NameRUSCH TRULED ADULT RECHARGEABLE BATTERY
Type of DeviceBATTERY, RECHARGEABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key5893415
MDR Text Key52655449
Report Number3011137372-2016-00243
Device Sequence Number1
Product Code FCO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/05/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0055502
Device Lot Number1451V3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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