8010042-2018-00601
Report
- Report Number
- 8010042-2018-00601
- Event Type
- Malfunction
- Date Received
- November 9, 2018
- Date of Event
- October 31, 2018
- Report Date
- December 5, 2018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- OTHER
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).
THE VENTILATOR WAS NOT INVESTIGATED BY OUR FIELD SERVICE ENGINEER SINCE A THIRD PARTY SERVICE PROVIDER PERFORMS REPAIR AND SERVICE AT THE USER FACILITY. NO INFORMATION ABOUT ANY REPLACED PARTS OR CURRENT STATUS OF THE COMPRESSOR HAS BEEN PROVIDED. BASED ON PRIOR INVESTIGATIONS, THE MOST PROBABLE CAUSE OF THIS FAILURE IS A LEAKAGE IN THE STANDBY VALVE RESULTING IN WRONG PRESSURE MEASUREMENT. THE STANDBY VALVE SHALL PUT THE COMPRESSOR IN STANDBY WHEN WALL AIR IS CONNECTED AND SHALL START TO SUPPLY COMPRESSED AIR WHEN NO WALL AIR IS CONNECTED. HOWEVER, THE TRUE ROOT CAUSE CANNOT BE DETERMINED WITHOUT FURTHER INFORMATION AND INVESTIGATION OF THE STANDBY VALVE. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC (B)(4). CONTACT PERSON: (B)(4).
IT WAS REPORTED THAT THE COMPRESSOR MOTOR WAS MAKING NOISE AND GOING INTO STANDBY. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).
IMPORTER REF. #:(B)(4). MANUFACTURER REF. #: (B)(4).
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |