8010042-2018-00436
Report
- Report Number
- 8010042-2018-00436
- Event Type
- Malfunction
- Date Received
- August 22, 2018
- Date of Event
- July 20, 2018
- Report Date
- September 10, 2018
- PMA / PMN Number
- K123149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA
- 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).
THE INVESTIGATION OF THE RETURNED EXPIRATORY CHANNEL PRINTED CIRCUIT (PC) BOARD HAS BEEN COMPLETED. THIS BOARD CONTAINS ELECTRONICS WHICH INCLUDE MICROPROCESSOR FOR CONTROL OF THE SAFETY VALVE FUNCTIONS IN THE INSPIRATORY SECTION OF THE DEVICE. THE PC-BOARD WAS INSTALLED IN A REFERENCE SYSTEM FOR SIMULATED USE TESTING. THE PRE-USE CHECK FAILED THE INTERNAL LEAKAGE TEST SINCE THE SAFETY VALVE IS OPEN, WHEN IT WAS EXPECTED TO BE CLOSED. THE CONCLUSION OF THE INVESTIGATION IS THAT THE ISSUE OCCURRED, DUE TO A SHORT CIRCUIT IN A CAPACITOR THAT IS PART OF THE ELECTRONICS FOR SAFETY VALVE FUNCTION. THE ROOT CAUSE OF WHY THE CAPACITOR FAILED HAS NOT BEEN DETERMINED. THE DEVICE LOGS ARE CONFIRMING THE REPORTED EVENT. WE COULD TRACE BACK THE REPORTED PROBLEM TO JULY 20, THEREFORE THE DATE OF EVENT WAS DETERMINED AS 07/20/2018. 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).
IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).
IMPORTER REF. #: (B)(4). MANUFACTURER REF. #: (B)(4).
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |