MAUDE Adverse Event Report: VERATHON MEDICAL BLADDERSCAN PRIME BATTERY CHARGER; ULTRASONIC PULSED ECHO IMAGING SYSTEM

Model Number 0400-0130

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

The batteries and the charger were retrieved from the customer by a verathon representative and are in transit to verathon headquarters for evaluation.At the time of the report the batteries and charger have not been received.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

The customer reported that the prime battery charger emitted smoke when connected to the wall and needed to be unplugged for safety concerns.Reportedly the batteries were in the charger at the time, however it appeared the smoke was emitted from the back of the charger itself.No patient harm was reported.

Manufacturer Narrative

The bladderscan prime charger was received by verathon.The initial visual inspection revealed moisture ingress with a residue present on an internal printed circuit board (pcb).The charger was sent to a third party for chemical composition testing, the result of which indicate the residue contained sodium chloride (nacl).Verathon continues to investigate the source of the residual nacl and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Manufacturer Narrative

A capacitor on the pcb of the battery charger was noted to be burned, this is likely due to the ingress of a fluid.The residue left by the fluid was identified by chemical composition testing to contain sodium chloride.The residue on the pcb was located under both battery wells.In addition, the shape of the residue matched the shape of the battery wells themselves.Based on the location and the shape, it is likely that the sodium chloride solution entered the charger through the battery well of the charger, after assembly.The manufacturing processes were reviewed and sodium chloride is not used during the manufacturing of the battery charger.In addition, the customer indicated they did not use a sodium chloride solution on the battery charger at any time.Therefore, the source of the sodium chloride fluid residue could not be confirmed.Review of the complaint history for this device determined that the reported event is an isolated incident.No other reports of smoking have been received for battery chargers used in conjunction with the bladderscan prime.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: BLADDERSCAN PRIME BATTERY CHARGER
• Type of Device: ULTRASONIC PULSED ECHO IMAGING SYSTEM
• 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: 6749342
• MDR Text Key: 81225570
• Report Number: 3022472-2017-00006
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K153101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0400-0130
• Device Catalogue Number: 0400-0130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2017
• Initial Date FDA Received: 07/27/2017
• Supplement Dates Manufacturer Received: 09/14/2017; 11/20/2017
• Supplement Dates FDA Received: 10/13/2017; 11/21/2017
• 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