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

Catalog Number 0055502

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 04/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint was confirmed, but the root cause is unknown.Upon receipt the rechargeable led cartridge was visually examined for any signs of damage, misuse/abuse and no issues were noted.An attempt was made to charge the cartridge with the charging unit that is shipped in the kit with the handle and led cartridge.The red glowing charging light would blink indicating an internal charging mode failure.The cartridge was destructively inspected and a red wire was found to had either never been connected, or at some point during the normal operation time frame became disconnected from the led driving module.The complaint has been confirmed however the root cause cannot be established with the current complaint information available.No further action required.

Event Description

The customer alleges that the device failed.Battery failing.

• 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: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5623696
• MDR Text Key: 44138178
• Report Number: 3011137372-2016-00087
• 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
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0055502
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2016
• Date Manufacturer Received: 04/11/2016
• 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: Unknown
• Patient Sequence Number: 1