FDA Adverse Event
Malfunction
Summary report: N
CONNECTED OR CART, 120 V
MDR report key: 17401520
·
Received July 26, 2023
Report
- Report Number
- 0002936485-2023-00727
- Event Type
- Malfunction
- Date Received
- July 26, 2023
- Date of Event
- June 1, 2023
- Report Date
- July 25, 2024
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- BZN
- UDI-DI
- 00858701006360
- 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
THE DEVICE WAS RECEIVED AT THE LOCAL SERVICE FACILITY FOR INVESTIGATION. THE TECHNICAL SERVICE REPORT INDICATES: MONITOR MOUNTING BRACKET REPLACED - BRACKET WORKING TO MANUFACTURER SPECIFICATIONS. PROBABLE ROOT CAUSE: MONITOR ARM DESIGN. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN.
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 DRIFTING OF THE CART ARM.
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS DRIFTING OF THE CART ARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 645265 | CONNECTED OR CART, 120 V | CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) | BZN | STRYKER ENDOSCOPY-SAN JOSE | 00858701006360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |