MAUDE Adverse Event Report: GE VINGMED ULTRASOUND AS VSCAN EXTEND DUAL; ULTRASOUND PULSED DOPPLER IMAGINGSYS

Lot Number VH164967LL

Device Problem Flare or Flash (2942)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2022

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The initial reporter is located outside the u.S.And therefore this information is not provided due to country privacy laws.Legal manufacturer: hcs horten - strandpromenaden 45 norway horten vestfold, n-3191.Ge healthcare's investigation is on-going at this time.

Event Description

The customer reported the vscan extend battery needed to be replaced.A ge healthcare service engineer went onsite and while replacing the vscan extend lithium-ion phone battery the battery smoldered and caught fire.Due to the self-extinguishing materials the fire did not spread.No injury occurred.

Manufacturer Narrative

Gehc's investigation has completed.The device was obtained and analyzed, and the service engineer involved was interviewed as part of the investigation.Additionally, historical product data was reviewed to determine frequency and no similar incidents have occurred within the past three years.It has been concluded that the service engineer improperly serviced the vscan extend while at the customer site and punctured a charged battery causing the fire.The vscan extend was replaced to correct the issue.The risk analysis concluded the level is afap and all mitigations are effective.No further action will be taken at this time.

• Brand Name: VSCAN EXTEND DUAL
• Type of Device: ULTRASOUND PULSED DOPPLER IMAGINGSYS
• Manufacturer (Section D): GE VINGMED ULTRASOUND AS; strandpromenaden 45; horten N-319 1; NO N-3191
• Manufacturer (Section G): GE VINGMED ULTRASOUND AS; strandpromenaden 45; horten N-319 1; NO N-3191
• Manufacturer Contact: joseph tamblyn ; 9900 w innovation dr; mail drop: rp-2130 / b4422; wauwatosa, WI 53226-4856
• MDR Report Key: 16283387
• MDR Text Key: 308930530
• Report Number: 9610482-2023-00001
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K180995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: VH164967LL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1