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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
Catalog Number IAP-0500
Device Problems Pressure Problem (3012); Incomplete or Inadequate Connection (4037)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/03/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) alarmed for purge failure on start-up therefore the patient was placed on another console without difficulty.There was no report of patient complications, serious injury or death.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) alarmed for purge failure on start-up therefore the patient was placed on another console without difficulty.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4).No part or recorder strip was returned to teleflex for investigation therefore the reported complaint of the purge failure alarm is not able to be confirmed.The root cause of the complaint is undetermined.If the part is returned or additional information is received at a later day, a full investigation will be completed.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.
 
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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 Key8936710
MDR Text Key155801313
Report Number3010532612-2019-00294
Device Sequence Number1
Product Code DSP
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 08/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIAP-0500
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received10/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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