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

Qn#(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The customer alleges that the device failed.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.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 not energize.The cartridge was destructively inspected.Visual signs of corrosion were found on top of the lithium-ion battery and the small led electronic driving module.The complaint has been confirmed.The lithium-ion battery leaked causing destructive corrosion inside the led cartridge housing that prevented the battery from charging.Corroding batteries could be the result of age, extreme heat and/or cold, or contact with other corrosive materials.A root cause for the issue could not be determined.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 device failed.

• 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: 5609337
• MDR Text Key: 43688270
• Report Number: 3011137372-2016-00085
• 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: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2016
• 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