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

Model Number VSCAN EXTEND DUAL P

Device Problem Failure to Run on Battery (1466)

Patient Problem Cardiac Arrest (1762)

Event Date 02/13/2021

Event Type  Death  

Manufacturer Narrative

Patient information could not be obtained due to country privacy laws.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 - (b)(4).Ge healthcare's investigation is ongoing at this time.

Event Description

The customer states that the reliability of the vscan extend battery is poor.The battery resilience is affecting the customer's ability to provide point of care imaging.The situation they provided says, "attended a traumatic cardiac arrest following a stabbing.During the incident we attempted to use the ultrasound to identify if the patient had a cardiac tamponade, however the unit had failed to turn on and therefore were unable to identify whether the patient had a tamponade.The patient was pronounced deceased shortly afterwards." therefore, gehc understands this to mean the customer is alleging the failure of the device to function limited and/or impeded the ability to provide the proper possible treatment (e.G.Pericardiocentesis, the ability to place a needle using ultrasound to guide placement into the sac that holds what is assumed to be the most fluid around the heart, based upon patient symptoms).

Manufacturer Narrative

Gehc investigation has completed.The device was returned to gehc for evaluation, and gehc was able to evaluate the device.Additionally, gehc and the customer were in communication with one another to aid in the investigation of the issue.Gehc conclusion is that the device is working as designed, and the customer had not followed instructions regarding regular device charging maintenance.The battery was drained of power which caused the inability of the device to bootup when inserting the battery.The customer was advised of device charging maintenance, and no further actions are being taken by gehc at this time.

• Brand Name: VSCAN EXTEND DUAL PROBE
• Type of Device: DIAGNOSTIC IMAGING ULTRASOUND
• Manufacturer (Section D): GE VINGMED ULTRASOUND AS; strandpromenaden 45; horten N-319 1; NO N-3191
• MDR Report Key: 11627125
• MDR Text Key: 244176178
• Report Number: 9610482-2021-00001
• 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: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VSCAN EXTEND DUAL P
• Device Lot Number: VH263271SZ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/07/2021
• Supplement Dates Manufacturer Received: 03/08/2021; 03/08/2021
• Supplement Dates FDA Received: 06/17/2021; 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death