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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM 176
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MAQUET CRITICAL CARE AB SUPPORT ARM 176 Back to Search Results
Catalog Number 6405976
Device Problem Mechanical Problem (1384)
Patient Problem No Patient Involvement (2645)
Event Date 01/23/2015
Event Type  malfunction  
Event Description
It was reported that the support arm had cracks.There was no patient involvement.(b)(4).
 
Manufacturer Narrative
The part has been requested back for investigation.A supplemental medwatch will be submitted when the investigation is completed.
 
Manufacturer Narrative
The broken support arm was received back for investigation, wherein visual inspection of the support arm confirmed the reported cracks.The support arm was manufactured in august of 2002.The position of the break indicates that the support arm had veen overloaded, however, the true cause for the broken support arm/ has/can not be determined from this investigation.The support arm is designed and tested according to the standard en 60601-01.
 
Event Description
(b)(4).
 
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Brand Name
SUPPORT ARM 176
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
solna
SW 
Manufacturer Contact
magnus lindqvist
2 roentgenvagen
solna S-171-54
SW   S-17154
7307705
MDR Report Key4524235
MDR Text Key5411928
Report Number8010042-2015-00048
Device Sequence Number1
Product Code IOY
Combination Product (y/n)N
Reporter Country CodeEI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,company representati
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6405976
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/23/2015
Initial Date FDA Received02/11/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/18/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/01/2002
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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