FDA Adverse Event Malfunction Summary report: N

COMPRESSOR MINI

MDR report key: 8499654 · Received April 10, 2019

Report

Report Number: 8010042-2019-00250
Event Type: Malfunction
Date Received: April 10, 2019
Date of Event: March 15, 2019
Report Date: April 10, 2019
Manufacturer: MAQUET CRITICAL CARE AB
Product Code: BTI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

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). FIELD SERVICE ENGINEER (FSE) WHO WAS DISPATCHED TO THE HOSPITAL DETERMINED THAT THE STANDBY VALVE WAS FAULTY. THE FSE REPAIRED THE STANDBY VALVE, TESTED THE COMPRESSOR AND FOUND IT FUNCTIONING PROPERLY. THE COMPRESSOR WAS RETURNED TO SERVICE. REPAIR WAS DONE ON SITE AND NO PARTS WERE REPLACED. THE EVALUATION VENTILATOR'S LOGS TO WHICH IT IS SAID THAT THE COMPRESSOR WAS CONNECTED DO NOT CONTAIN INFORMATION TO ENABLE US DETERMINE OF HOW THE COMPRESSOR WAS MALFUNCTIONING. THE TRUE FAILURE AND THE CAUSE OF THE REPORTED PROBLEM HAS THEREFORE NOT BEEN DETERMINED.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE COMPRESSOR'S STANDBY VALVE WAS NOT DELIVERING PRESSURE ACCURATELY. (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
295412	COMPRESSOR MINI	COMPRESSOR, AIR, PORTABLE	BTI	MAQUET CRITICAL CARE AB

Patients

Seq	Age	Sex	Outcome	Treatment
1