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

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.

• Brand Name: RUSCH TRULED ADULT RECHARGEABLE BATTERY
• Type of Device: BATTERY, 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 Key: 5893415
• MDR Text Key: 52655449
• Report Number: 3011137372-2016-00243
• Device Sequence Number: 1
• Product Code: FCO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0055502
• Device Lot Number: 1451V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2016
• 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
• Patient Sequence Number: 1