MAUDE Adverse Event Report: GREATBATCH MEDICAL POWERPRO STERILE TRANSFER BATTERY LARGE; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number PRO3115

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The alleged melted pro3115 is not expected to be returned for evaluation and review.At this time further assessment is being requested from the user.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that pro3115 device was being used for the second time for the day.The use was during an unknown surgery on an unknown date.The battery was reported as becoming warm and melting.There was no report of injury to patient or the user.Further assessment information has been requested; however, no answer has been received to date.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

No further assessment has been received from the reporter.The alleged melted pro3115 is not expected to be returned for evaluation and review.This complaint of melted device is unable to be verified and a root cause cannot be determined.The device history record was requested from the contract manufacturer; however, the serial number provided was stated as being invalid.A two-year review of complaint history revealed there has been a total of two complaints, regarding two devices, for this device family and failure mode.During this same time frame 30,553 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 0.00007.Per the instructions for use, the user is advised the following: cleaning and sterilization: -do not use battery cases while warm.Allow adequate time for cooling prior to use.Do not immerse in liquid or cover with damp cloth to cool.Cool by exposure to room temperature.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: POWERPRO STERILE TRANSFER BATTERY LARGE
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): GREATBATCH MEDICAL; calle 5 norte no. 511; ciudad industrial; tijuana, 22444 ; MX 22444
• MDR Report Key: 9375049
• MDR Text Key: 202790796
• Report Number: 1017294-2019-00153
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PRO3115
• Device Lot Number: 00000393
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1