FDA Adverse Event
Malfunction
Summary report: N
SERVO-I BASE UNIT
MDR report key: 20977702
·
Received December 19, 2024
Report
- Report Number
- 8010042-2024-0002109
- Event Type
- Malfunction
- Date Received
- December 19, 2024
- Report Date
- December 19, 2024
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K123149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE INTERNAL EVALUATION DETERMINED THAT THE COMPLAINT IS A DUPLICATE. FURTHER INFORMATION WILL BE PROVIDED AS A FOLLOW-UP TO THE REPORT WITH MFG REPORT NUMBER: 8010042-2024-0002107.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST DURING PRE-USE CHECK WITH A MESSAGE 'PRESSURE TRANSDUCER DIFFERENCE >5 CMH2O '. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4).
Description of Event or Problem · 0
MANUFACTURER'S REF: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2024439 | SERVO-I BASE UNIT | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | MAQUET CRITICAL CARE AB | 6487800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |