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
Device Problems Mechanical Problem (1384); Unintended Movement (3026)
Patient Problem Extubate (2402)
Event Type  malfunction  
Event Description
Imp ref # (b)(4).
 
Manufacturer Narrative
More info surrounding the event has been sought.A supplemental medwatch will be provided when investigation is finished.
 
Manufacturer Narrative
Our investigation of the returned support arm has been completed.The investigation showed no indications of low friction in the joints.According to the customer, they had tightened the support arm before returning it.The support arm was stretched out and bent several times without friction reduction or a self-lowering at the level of the joints.The support arm joints were dis-mounted to check the friction rings.The friction rings were not worn out or damaged.No fault could be confirmed from inspection of the friction rings or the joints themselves.According to the installation instructions for the support arm the support arm joints shall be adjusted if necessary.Our conclusion is there is no fault with the support arm, the cause for the reported incident was that the support arm joints were not tightened.(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 Contact
magnus lyndqvist
solna S-171- 54
SW   S-171 54
7307705
MDR Report Key4420209
MDR Text Key18790029
Report Number8010042-2014-00549
Device Sequence Number1
Product Code IOY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Date Manufacturer Received11/07/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-