SERVO-S BASE UNIT
Report
- Report Number
- 8010042-2024-00842
- Event Type
- Malfunction
- Date Received
- May 24, 2024
- Date of Event
- May 22, 2024
- Report Date
- May 24, 2024
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K123149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE ISSUE OCCURRED DURING TRANSPORT BETWEEN UNITS. IT HAS BEEN CONCLUDED THAT THE ARM HAS BEEN OVERLOADED AND SUBJECTED TO A FORCE GREATER THAT IT WAS MANUFACTURED TO SUSTAIN. THE ROOT CAUSE TO THE REPORTED ISSUE HAS NOT BEEN DETERMINED. A CORRECTION OF FIELD: # D1 BRAND NAME, #D2B PRODUCT CODE, #D2A PRODUCT CODE DESCRIPTION. #D4 VERSION OR MODEL #, #H4 MANUFACTURE DATE WAS REQUIRED. D1 - BRAND NAME - PREVIOUS BRAND NAME: SUPPORT ARM 177 - CORRECTED BRAND NAME: SERVO-S BASE UNIT, PRODUCT CODE D2B ¿ PREVIOUS PRODUCT CODE: IOY - CORRECTED PRODUCT CODE: CBK, PRODUCT CODE DESCRIPTION. D2.A: - PREVIOUS CODE DESCRIPTION: SUPPORT, ARM, - CORRECTED CODE DESCRIPTION: VENTILATOR, CONTINUOUS, FACILITY USE, D4 - VERSION OR MODEL #: - PREVIOUS VERSION OR MODEL #: SUPPORT ARM 177 - CORRECTED VERSION OR MODEL #: 6640440 #H4 MANUFACTURE DATE ¿ PREVIOUS MANUFACTURE DATE: BLANK, - CORRECTED MANUFACTURE DATE: 01/27/2006.
IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4).
MANUFACTURER'S REF. #: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2321340 | SERVO-S BASE UNIT | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | MAQUET CRITICAL CARE AB | 6640440 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |