FDA Adverse Event
Malfunction
Summary report: N
CONNECTED OR MOUNT
MDR report key: 20071900
·
Received August 26, 2024
Report
- Report Number
- 0002936485-2024-00601
- Event Type
- Malfunction
- Date Received
- August 26, 2024
- Date of Event
- August 2, 2024
- Report Date
- November 27, 2024
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- BZN
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: STRUGGLING TO USE THE VIDEO TOWER. PROBABLE ROOT CAUSE: MONITOR ARM DESIGN. 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 THE CART ARM WAS DRIFTING.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE CART ARM WAS DRIFTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 882231 | CONNECTED OR MOUNT | CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) | BZN | STRYKER ENDOSCOPY-SAN JOSE | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |