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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000320
Device Problem Failure to Run on Battery (1466)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/11/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) powered off as soon as the user unplugged it from ac power at the bedside to begin transport.As a result, the iabp was swapped out with the hospital's iabp.There was no report of patient complications or injury.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) powered off as soon as the user unplugged it from ac power at the bedside to begin transport.As a result, the iabp was swapped out with the hospital's iabp.There was no report of patient complications or injury.
 
Manufacturer Narrative
Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of "pump powered off when the user unplugged it from ac power" is not confirmed.The returned power supply passed visual and functional test specifications.The root cause of the complaint is undetermined.A device history record (dhr) review was not performed.There was no confirmed product failure with the returned sample.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
 
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Brand Name
AUTOCAT2 WAVE
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key11065541
MDR Text Key223592800
Report Number3010532612-2020-00392
Device Sequence Number1
Product Code DSP
UDI-Device Identifier30801902051715
UDI-Public30801902051715
Combination Product (y/n)N
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN000320
Device Catalogue NumberIAP-0500
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2020
Date Manufacturer Received01/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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