FDA Adverse Event
Malfunction
Summary report: N
SERVO-S
MDR report key: 8850356
·
Received August 1, 2019
Report
- Report Number
- 8010042-2019-00563
- Event Type
- Malfunction
- Date Received
- August 1, 2019
- Date of Event
- May 1, 2019
- Report Date
- July 7, 2020
- 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 CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
THE REPORTED VENTILATOR UNIT WAS INVESTIGATED BY THE HOSPITAL, AN EXCESSIVE AMOUNT OF MOISTURE HAS BEEN FOUND IN THE AIR GAS MODULE. THE AIR GAS MODULE HAS NOT BEEN REPLACED BY THE HOSPITAL. ACCORDING TO THE HOSPITAL THE SOURCE OF THE WATER INSIDE AN AIR GAS MODULE IS MOIST AIR FROM THE HOSPITAL'S EXTERNAL COMPRESSOR. ACCORDING TO THE USER´S MANUAL MAXIMUM LEVELS OF WATER,(H2O < 7 G/M3) IN THE SUPPLIED GASES TO THE VENTILATOR MUST NOT BE EXCEEDED. H3 OTHER TEXT : 4117.
Description of Event or Problem · 0
MANUFACTURER REF.#: 232228.
Description of Event or Problem · 1
IT WAS REPORTED THAT WATER WAS FOUND IN THE AIR MODULE OF THE VENTILATOR. THERE WAS NO PATIENT HARM. MANUFACTURER REF.#: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 646123 | SERVO-S | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | MAQUET CRITICAL CARE AB | SERVO-S |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |