Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM 177
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CRITICAL CARE AB SUPPORT ARM 177 Back to Search Results
Catalog Number 6481720
Device Problem Mechanical Problem (1384)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
It was reported that the support arm broke.There was no pt involvement.(b)(4).
 
Manufacturer Narrative
No parts are available for investigation since they were scrapped by the customer.Due to this fact, the root cause of the breakage cannot be established.According to the received info the support arm broke at the joint nearest to the bracket.No info regarding manufacturing date of the support arm has been received.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SUPPORT ARM 177
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
solna
SW 
Manufacturer (Section G)
MAQUET CRITICAL CARE AB
solna S-17 154
SW   S-17154
Manufacturer Contact
janice pevide
45 barbour pond dr
wayne, NJ 07470
9737097753
MDR Report Key4122014
MDR Text Key4919194
Report Number8010042-2014-00424
Device Sequence Number1
Product Code IOY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/19/2014,08/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6481720
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/20/2014
Event Location Hospital
Date Report to Manufacturer08/22/2014
Date Manufacturer Received08/20/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-