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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I-C20 GAS-MACHINE, ANESTHESIA

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MAQUET CRITICAL CARE AB FLOW-I-C20 GAS-MACHINE, ANESTHESIA Back to Search Results
Model Number C20
Event Date 03/17/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that when replacing a failing internal power backup battery, our company representative noticed that the battery had leaked battery acid into the battery compartment of the anesthesia workstation. There was no injury reported. (b)(4).

 
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Brand NameFLOW-I-C20
Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
roentgenvagen 2
solna
Manufacturer (Section G)
MAGNUS LINDQVIST
maquet critical care ab
röntgenvägen 2, se-171 54
solna
SW 
Manufacturer Contact
maquet critical care ab
röntgenvägen 2, se-171 54
solna  
MDR Report Key8451207
Report Number8010042-2019-00202
Device Sequence Number1
Product CodeBSZ
Report Source Manufacturer
Reporter Occupation
Report Date 04/25/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberC20
Device Catalogue Number6677200
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/15/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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