FDA Adverse Event
Malfunction
Summary report: N
PKG STANDARD CART W ISOLATION TRANSFORMER
MDR report key: 20258876
·
Received September 19, 2024
Report
- Report Number
- 0002936485-2024-00656
- Event Type
- Malfunction
- Date Received
- September 19, 2024
- Date of Event
- August 29, 2024
- Report Date
- December 3, 2024
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- BZN
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. PLEASE NOTE STRYKER IS NOT THE LEGAL MANUFACTURER OF THE DEVICE ON THIS INVESTIGATION. ALLEGED FAILURE: DOESN'T SEND POWER TO CONSOLES. PROBABLE ROOT CAUSE: ISOLATION TRANSFORMER DESIGN. POWER STRIP MALFUNCTION. USE ERROR. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS THERMAL EVENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS THERMAL EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1785576 | PKG STANDARD CART W ISOLATION TRANSFORMER | CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) | BZN | STRYKER ENDOSCOPY-SAN JOSE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |