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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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TELEFLEX INCORPORATED ARROW SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number IPN915319
Device Problems Failure to Zero (1683); Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 02/06/2022
Event Type  malfunction  
Event Description
Intra aortic balloon pump (iabp) failed to zero. Gray part did not pop out but stayed low. Defective device discarded and replaced by same type of device. This time iabp was working. Manufacturer response for system, balloon, intra-aortic and control, arrow (per site reporter). Med representative made aware and device returned to him by manager.
 
Event Description
Intra aortic balloon pump (iabp) failed to zero. Gray part did not pop out but stayed low. Defective device discarded and replaced by same type of device. This time iabp was working. Manufacturer response for system, balloon, intra-aortic and control, arrow (per site reporter). Med representative made aware and device returned to him by manager.
 
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Brand NameARROW
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
TELEFLEX INCORPORATED
po box 12600
durham NC 27709
MDR Report Key13598642
MDR Text Key286119433
Report Number13598642
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/18/2022,02/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberIPN915319
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F21J0042
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/18/2022
Event Location Hospital
Date Report to Manufacturer02/25/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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