SERVO-U
Report
- Report Number
- 8010042-2018-00431
- Event Type
- Malfunction
- Date Received
- August 20, 2018
- Report Date
- January 23, 2019
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K151814
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4).
GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC. 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4). THE FAULT CONDITION COULD NOT BE REPRODUCED OR CONFIRMED, WHEN THE VENTILATOR WAS INVESTIGATED ON SITE BY OUR FIELD SERVICE ENGINEER. AS A PREVENTIVE MEASURE THE AIR GAS MODULE WAS REPLACED. DESPITE SEVERAL REMINDERS THE AIR GAS MODULE WAS NOT RETURNED FOR OUR INVESTIGATION EVALUATION OF THE RECEIVED DEVICE LOGS SHOWS THAT THE MATCHING EVENT ON JULY 9 DURING THE TIME PERIOD 02:07 TO 02:44. THE ROOT CAUSE WHY THE VENTILATOR GENERATED ALARMS FOR HIGH AIR SUPPLY PRESSURE HAS NOT BEEN DETERMINED. BUT DUE TO THE REPORTED PART AND THAT NO NEW EVENT HAS BEEN REPORTED WE STILL CONCLUDE THAT MOST LIKELY CASE WAS A DEFECTIVE AIR GAS MODULE.
IT WAS REPORTED THAT THE VENTILATOR GENERATED AN ALARM FOR HIGH AIR SUPPLY PRESSURE. PATIENT INVOLVEMENT IS UNKNOWN. IMPORTER REF. #: (B)(4). MANUFACTURER REF. #: (B)(4).
IMPORTER REF. #: (B)(4). MANUFACTURER REF. #: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 637331 | SERVO-U | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |