FDA Adverse Event Malfunction Summary report: N

COMPRESSOR MINI

MDR report key: 8806730 · Received July 19, 2019

Report

Report Number: 8010042-2019-00524
Event Type: Malfunction
Date Received: July 19, 2019
Report Date: March 13, 2020
Manufacturer: MAQUET CRITICAL CARE AB
Product Code: BTI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

IT WAS REPORTED THAT THE COMPRESSOR WAS MAKING NOISE. OUR FIELD SERVICE ENGINEER REPLACED THE COMPRESSOR MOTOR WHERE AFTER THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATION AND WAS RETURNED TO CUSTOMER AND CLEARED FOR CLINICAL USE. A VISUAL INSPECTION OF THE RETURNED COMPRESSOR/MOTOR UNIT DID NOT SHOW ANY FAULTS OR DAMAGES TO THE UNIT. RESISTANCE MEASUREMENT OF THE RETURNED MOTOR CAPACITOR INDICATED THAT IT WAS FUNCTIONAL. MANUALLY TURNING THE COMPRESSOR ROTOR WENT WITHOUT RESISTANCE AND NO OTHER DEFICIENCIES WERE FOUND. THE COMPRESSOR/MOTOR UNIT WAS TESTED STANDALONE IN A TEST BENCH. WHEN IT WAS CONNECTED TO THE MAINS INLET, IT STARTED TO RUN AND COMPRESSED AIR WAS EFFICIENTLY GENERATED. THIS WAS TRIED SEVERAL TIMES WITH NO PROBLEMS ENCOUNTERED. THE REPORTED NOISE WAS NOTED WITHOUT BEING EXCEPTIONAL. THE CONCLUSION IN THIS MATTER IS THAT THE REPORTED NOISE COULD BE NOTICED BUT THE RETURNED COMPRESSOR/MOTOR FUNCTIONED WELL WHEN TESTED IN THE TEST BENCH DURING THE INVESTIGATION.

Description of Event or Problem · 0

MANUFACTURER'S REF.: (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE COMPRESSOR WAS MAKING NOISE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF.: (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
600614	COMPRESSOR MINI	COMPRESSOR, AIR, PORTABLE	BTI	MAQUET CRITICAL CARE AB	COMPR MINI 115V 60HZ

Patients

Seq	Age	Sex	Outcome	Treatment
1