MAUDE Adverse Event Report: GREATBATCH MEDICAL HALL LARGE LITHIUM BATTERY; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number L3000LG

Device Problem Fumes or Vapors (2529)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation and no photographic evidence has been provided.Therefore, the reported failure cannot be verified.The service history was reviewed, and no prior data was found.This device is a vendor item; therefore, the date of manufacture is unknown and a dhr review could not be performed.A two-year review of complaint history revealed there has been a total of 33 complaints, regarding 33 devices, for this device family and failure mode.During this same time frame 20,243 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.002.Per the instructions for use, the user is advised the following: warnings: inspect battery pack for damage prior to use.Do not use damaged battery packs.If battery pack is damaged and leakage or residue is noticed, do not allow it to come in contact with skin, eyes or clothing.Burns may result.The battery pack in this device may present risk of fire or chemical burn if mistreated.Do not disassemble, heat above 278 degrees f (137 degree c), or incinerate.Precautions: charge this battery using the hall lithium battery charger (l3000) only.Use of any non-approved charger may cause injury or damage to the battery.Do not drop, as this could damage the battery potentially creating an unsafe condition.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the l3000lg device was on the charger charging on (b)(6) 2019, when the battery began to give off fumes.The customer is reported to have removed the battery and placed it in a sink and the battery left a burn mark in the sink.There was no report of injury.There was no patient involvement.Further assessment information was requested; however, no further information has been received.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: HALL LARGE LITHIUM BATTERY
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): GREATBATCH MEDICAL; calle 5 norte no. 511; ciudad industrial; tijuana, 22444 ; MX 22444
• Manufacturer (Section G): GREATBATCH MEDICAL; calle 5 norte no. 511; ciudad industrial; tijuana, 22444 ; MX 22444
• Manufacturer Contact: john berga ; 11311 concept blvd.; largo, FL 33773 ; 7273995358
• MDR Report Key: 8659225
• MDR Text Key: 151945623
• Report Number: 1017294-2019-00063
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: L3000LG
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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