BASE UNIT SERVO-U
Report
- Report Number
- 8010042-2023-02570
- Event Type
- Malfunction
- Date Received
- December 28, 2023
- Report Date
- December 28, 2023
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K201874
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
IT WAS REPORTED THAT THE SIDE RAIL FOR A VENTILATOR WITH UNKNOWN SERIAL NUMBER WAS DAMAGED. NO INFORMATION WERE RECEIVED ABOUT HOW THE SIDE RAILS BECOME DAMAGED. 8 NEW SIDE RAILS HAS BEEN ORDERED TO REPLACED THE DAMAGED SIDE RAILS. THE ROOT CAUSE FOR THE DAMAGED SIDE RAIL COULD NOT BE DETERMINED BUT THE SIDE RAIL HAS MOST LIKELY BEEN EXPOSED TO A MECHANICAL FORCE GREATER THAN IT IS DESIGNED TO SUSTAIN. H3 OTHER TEXT : 4111.
DEVICE RELATED DATA QUALITY UPDATES ONLY. A CORRECTION OF FIELDS # D1 BRAND NAME, # D4 VERSION OR MODEL # WAS REQUIRED. D1 - BRAND NAME: PREVIOUS BRAND NAME: SERVO-U, CORRECTED BRAND NAME: BASE UNIT SERVO-U. D4 - VERSION OR MODEL #: PREVIOUS VERSION OR MODEL #: SERVO-U, CORRECTED VERSION OR MODEL #: 6694800. THE SERIAL NUMBER FOR THE MEDICAL DEVICE REFERRED TO IN THIS MEDICAL DEVICE REPORT HAS NOT BEEN RECEIVED, AND THEREFORE, NO UDI NUMBER CAN BE PROVIDED.
IT WAS REPORTED THAT THE SIDE RAIL FOR A VENTILATOR WITH UNKNOWN SERIAL NUMBER WAS DAMAGED. NO MORE DETAILS WERE PROVIDED. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF #: 950970
MANUFACTURER'S REF.#: (B)(4).
MANUFACTURER'S REF.#: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1530776 | BASE UNIT SERVO-U | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | MAQUET CRITICAL CARE AB | 6694800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |