FDA Adverse Event
Injury
Summary report: N
VIEWMATE Z ULTRASOUND CONSOLE WBATTERY ZS3
MDR report key: 10455364
·
Received August 26, 2020
Report
- Report Number
- 3004189859-2020-00005
- Event Type
- Injury
- Date Received
- August 26, 2020
- Date of Event
- August 24, 2020
- Report Date
- May 12, 2021
- Manufacturer
- ZONARE MEDICAL SYSTEMS, INC
- Product Code
- DRJ
- UDI-DI
- 05415067013361
- PMA / PMN Number
- K151175
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WAS RECEIVED AT THE VENDOR FOR ANALYSIS. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE CAUSE FOR THE REPORTED EVENT WAS ISOLATED TO THE CONSOLE SCAN ENGINE. THE DEVICE HISTORY RECORD WAS REVIEWED, NO ISSUES WERE NOTED.
Additional Manufacturer Narrative · 1
THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Description of Event or Problem · 1
WHEN THE SYSTEM WAS PLUGGED IN PRIOR TO A PROCEDURE, VISIBLE SMOKE WAS NOTED FROM THE SYSTEM. THERE WAS NO PATIENT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 919723 | VIEWMATE Z ULTRASOUND CONSOLE WBATTERY ZS3 | SYSTEM, SIGNAL ISOLATION | DRJ | ZONARE MEDICAL SYSTEMS, INC | H701336 | 7199207 | 05415067013361 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |