MAUDE Adverse Event Report: VERATHON MEDICAL BLADDERSCAN BVI 9400 RECHARGEABLE BATTERY PACK; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 0400-0066

Device Problems Fire (1245); Explosion (4006)

Patient Problem No Patient Involvement (2645)

Event Date 09/25/2018

Event Type  malfunction  

Manufacturer Narrative

Upon investigation it was determined that the bvi 9400 was returned to verathon for an unrelated servicing event on 19-sep-2018.The customer returned the bvi 9400 with one battery, date coded (b)(6) 2017, which was found functional during testing and was not replaced.The bvi 9400 and battery were returned to the customer following the completion of the servicing event.Photographs of the bladderscan bvi 9400 and associated packaging provided by the (b)(6) safety department on (b)(6) 2018 confirmed the reported event.The damage to the shipping box appeared to be isolated to the corner which housed the device battery during shipment.A complaint history search, date range 01-jan-2013 to current, revealed there have been no other reported fires associated with the bvi 9400 or the batteries used in conjunction with the bvi 9400.The bvi 9400 is being held at the (b)(6) facility until their investigation has been completed.The return of the device is anticipated.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

It was reported by the (b)(6) safety department that during the transportation of a bladderscan bvi 9400 device the shipment box began smoking and caught on fire.The package was removed and extinguished with a hand held extinguisher.No injuries were reported, in addition it was reported the damage was isolated to this one package.

Manufacturer Narrative

The bladderscan bvi 9400, remains from the damaged battery, and associated shipping materials were returned to verathon for evaluation.A visual inspection of the returned bvi 9400 showed the console and probe suffered smoke damage and had residue of the extinguisher material present on the surfaces.No other physical damage was observed.The remains from the damaged battery included four (4) of the cells that are used in the bvi 9400 battery.Three (3) of the four (4) cells were covered in char and extinguisher material, but appeared to be physically intact.One of the cells appeared to be free of char and extinguisher material.In addition, a severe dent was observed in the outer metal housing of the battery cell.The remaining cells nor the battery enclosure were returned for evaluation.The remains were sent for forensic evaluation.Due to the extent of the damage the root cause could not be conclusively determined; however, it is likely that the cause of the fire was an impact, crushing, or puncture of the battery during shipping and handling which then led to a mechanical failure of the battery.The dhr and service history of the device were reviewed.The device and battery were shipped in accordance with validated packaging configuration and no damage to the battery was observed during servicing.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: BLADDERSCAN BVI 9400 RECHARGEABLE BATTERY PACK
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): VERATHON MEDICAL; 20001 n creek pkwy; bothell WA 98011 8218
• Manufacturer (Section G): VERATHON MEDICAL; 20001 n creek pkwy; bothell WA 98011 8218
• Manufacturer Contact: corey kasbohm ; 20001 n creek pkwy; bothell, WA 98011-8218 ; 4256295760
• MDR Report Key: 8006999
• MDR Text Key: 125089387
• Report Number: 3022472-2018-00004
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00879123002259
• UDI-Public: (01)00879123002259(11)170614
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0400-0066
• Device Catalogue Number: 0400-0066
• Device Lot Number: 2017-06-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Date Manufacturer Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2017
• 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