SERVO-I
Report
- Report Number
- 8010042-2019-00010
- Event Type
- Malfunction
- Date Received
- January 8, 2019
- Date of Event
- December 17, 2018
- Report Date
- March 29, 2019
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K123149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- 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 PERON: (B)(4). OUR FSE (FIELD SERVICE ENGINEER) WAS ON SITE AND INVESTIGATED THE REPORTED ISSUE. THE FSE INFORMED US THAT THE ISSUE OCCURRED DUE TO MISUSE OF THE EQUIPMENT BY THE NURSE; FILLING THE HUMIDIFIER MORE THAN IT SHOULD BE. THE WATER REACHED TO CIRCUITS AND DAMAGED A PRINTED CIRCUIT BOARD. THE LOGS WERE NOT RECEIVED, BUT ACCORDING TO THE SERVICE REPORT THE VENTILATOR ALARMED FOR O2 SENSOR/CABLE AND PRINTED CIRCUIT BOARD RELATED ERRORS. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO USER ERROR.
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 PERON: (B)(4).
MANUFACTURER REF. #: (B)(4).
IT WAS REPORTED THAT WATER FROM THE HUMIDIFIER WENT INTO THE VENTILATOR DURING PATIENT TREATMENT, CAUSING DAMAGE TO THE PRINTED CIRCUIT BOARDS. THERE WAS NO PATIENT HARM. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 22459 | SERVO-I | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |