COMPRESSOR MINI COMPR MINI 115V 60HZ 6481779

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-20 for COMPRESSOR MINI COMPR MINI 115V 60HZ 6481779 manufactured by Maquet Critical Care Ab.

Event Text Entries

[184288762] It was reported that the compressor was going into standby intermittently. There was no patient harm. Manufacturer ref. #: (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010042-2020-00168
MDR Report Key9859110
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-20
Date of Report2020-03-27
Date of Event2020-03-17
Date Mfgr Received2020-03-17
Date Added to Maude2020-03-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer StreetROENTGENVAGEN 2
Manufacturer CitySOLNA
Manufacturer CountryUS
Manufacturer G1MAQUET CRITICAL CARE AB
Manufacturer StreetROENTGENVAGEN 2
Manufacturer CitySOLNA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOMPRESSOR MINI
Generic NameCOMPRESSOR, AIR, PORTABLE
Product CodeBTI
Date Received2020-03-20
Model NumberCOMPR MINI 115V 60HZ
Catalog Number6481779
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMAQUET CRITICAL CARE AB
Manufacturer AddressROENTGENVAGEN 2 SOLNA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-20

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