SERVO-I
Report
- Report Number
- 8010042-2018-00339
- Event Type
- Malfunction
- Date Received
- July 6, 2018
- Report Date
- July 31, 2018
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K123149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- 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 PERON: (B)(4). DURING PREVENTIVE MAINTENANCE PERFORMED BY OUR FIELD SERVICE ENGINEER, A DAMAGE ON THE CONTROL PC BOARD WAS NOTED. A PROTECTIVE CAP OVER AN INDUCTOR IN THE POWER CIRCUITRY TO THE PROCESSOR WAS MISSING. THE PC BOARD WAS REPLACED BUT NOT RETURNED. THE VENTILATOR PASSED ALL SAFETY AND FUNCTIONAL TESTS AND WAS RETURNED FOR CLINICAL USE. PROVIDED PHOTO CONFIRM THE REPORTED ISSUE. THE ROOT CAUSE OF THE MISSING PROTECTIVE CAP HAS NOT BEEN DETERMINED.
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).
IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, A DAMAGE ON THE CONTROL PC BOARD WAS NOTED. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).
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 |
|---|---|---|---|---|---|---|---|
| 510459 | SERVO-I | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |