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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CARDIAC UNKNOWN DUMMY MATERIAL
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ARROW INTERNATIONAL INC. CARDIAC UNKNOWN DUMMY MATERIAL Back to Search Results
Catalog Number CARDIAC UNKNOWN
Device Problem Mechanical Problem (1384)
Event Date 02/08/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that after the intra-aortic balloon (iab) was inserted the staff experienced many alarms from the intra-aortic balloon pump (iabp).Alarms included "drain task incomplete" and "purge failure".There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
Qn#(b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of "many alarms" is not able to be confirmed.The root cause of the complaint is undetermined.The specific serial number was not reported, but a device history record (dhr) review was conducted for all the lot numbers/serial numbers at this account with no relevant findings.All devices passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
 
Event Description
It was reported that after the intra-aortic balloon (iab) was inserted the staff experienced many alarms from the intra-aortic balloon pump (iabp).Alarms included "drain task incomplete" and "purge failure".There was no report of patient complications, serious injury or death.
 
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Brand Name
CARDIAC UNKNOWN DUMMY MATERIAL
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key11414545
MDR Text Key239509684
Report Number3010532612-2021-00063
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCARDIAC UNKNOWN
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received04/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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