8010042-2018-00542
Report
- Report Number
- 8010042-2018-00542
- Event Type
- Malfunction
- Date Received
- October 12, 2018
- Date of Event
- September 19, 2018
- Report Date
- October 25, 2018
- PMA / PMN Number
- K123149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- 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 INVESTIGATION OF THE RETURNED EXPIRATORY CHANNEL PC BOARD HAS BEEN COMPLETED. THIS BOARD CONTAINS ELECTRONICS WHICH INCLUDE MICROPROCESSOR FOR HANDLING OF THE MEASUREMENT OF EXPIRATORY FLOW. SOME OF THE OTHER FUNCTIONS OF THE BOARD ARE THE MEASUREMENT OF AIRWAY PRESSURE IN BOTH INSPIRATORY AND EXPIRATORY SECTION, CONTROL OF THE SAFETY VALVE FUNCTIONS IN THE INSPIRATORY SECTION OF THE DEVICE AND DRIVING THE PEEP VALVE. THE PC-BOARD WAS INSTALLED IN A REFERENCE SYSTEM FOR SIMULATED USE TESTING. A TECHNICAL ALARM WAS GENERATED, INDICATING A COMMUNICATION FAULT. THE PRE-USE CHECK FAILED THE FLOW TRANSDUCER TEST. THE CONCLUSION OF THE INVESTIGATION IS THAT THE ISSUE OCCURRED, DUE TO A FAULTY CENTRAL PROCESSOR UNIT (CPU) RESPONSIBLE FOR FLOW MEASUREMENTS AND COMMUNICATIONS TO OTHER PC BOARDS IN THE VENTILATOR. NO DEVICE LOG HAS BEEN RECEIVED. 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 A SPARE PART EXPIRATORY CHANNEL PRINTED CIRCUIT BOARD WAS FAULTY. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).
MANUFACTURER REF. #: (B)(4).
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |