MAUDE Adverse Event Report: GE VINGMED ULTRASOUND AS VSCAN EXTEND DUAL; DIAGNOSTIC ULTRASOUND SYSTEM

Model Number H41212RN

Device Problems Fire (1245); Smoking (1585); Sparking (2595); Battery Problem (2885)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 05/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Legal manufacturer: hcs (b)(4) - (b)(4).

Event Description

While a vscan extend was undergoing repair the repair technician noted the battery cover was bulging and not completely secured.The technician pressed the cover in an attempt to close it when the battery sparked, and shortly afterwards started smoking and then burst info flames.No injury or property damage occurred as a result.

Manufacturer Narrative

Ge's investigation has completed.The actual device was evaluated, and it was determined that there is no evidence to indicate that this failure was due to a puncture of the battery.It was caused by the pressure of the back of the phone being replaced.This increased the pressure within the battery resulting in gases being vented and subsequent ignition leading to a fire.Complaint and service data was reviewed and no other occurrence of the vscan extend bursting into flames could be found.However, other instances of bulging batteries were noted, and the investigation turned to trying to reproduce the issue using bulging batteries.This testing concluded battery bulging by itself did not cause the vscan extend to burst into flames.It was further concluded that battery bulging occurs when an aging battery maintains a 100% state of charge (i.E.Doesn't get discharged properly) due to a lack of charge/discharge management via software, which is currently the design of the vscan extend.Therefore, ge's actions to address the bulging batteries is to change the software design going forward to allow for proper charging/discharging cycles.Additionally, service procedures for handling a bulging battery of a vscan extend were reviewed and it has been concluded that current procedures for replacement and disposal are adequate.

• Brand Name: VSCAN EXTEND DUAL
• Type of Device: DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer (Section D): GE VINGMED ULTRASOUND AS; strandpromenaden 45; horten N-319 1; NO N-3191
• MDR Report Key: 8737525
• MDR Text Key: 149475618
• Report Number: 9610482-2019-00002
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• PMA/PMN Number: K180995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: H41212RN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1