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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
Device Problem Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Date 04/04/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the hospital staff noticed that the lid for the internal battery compartment was missing. There was no patient involvement. (b)(4).
 
Manufacturer Narrative
The problem description states that the battery lid cover for the battery compartment was not mounted at the factory. Our work instructions have been updated since this device was manufactured. Our conclusion is that the lack of (missing) battery lid cover was likely caused by a single assembly line operator error at the time. (b)(4). Ref. Exemption #: e2018003. (b)(4). (b)(6).
 
Event Description
(b)(4).
 
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Brand NameFLOW-I C20
Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
solna
SW
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 Key7433002
MDR Text Key105695787
Report Number8010042-2018-00187
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K160665
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberC20
Device Catalogue Number6677200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/15/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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