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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE JAPANESE; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE JAPANESE; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000325
Device Problem Mechanical Problem (1384)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/26/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
There was no patient involvement.It was reported that during operational checking of the intra-aortic balloon pump (iabp) (battery- operated) at the distributor's site, after about 60 minutes, a "large helium leak" alarm and "high base line" alarm occurred.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of "high baseline and helium loss alarm" is not confirmed.The returned m-force motor driver assembly passed visual and functional test specifications.The root cause of the complaint is undetermined.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 risk.This will be monitored for any developing trends.
 
Event Description
There was no patient involvement.It was reported that during operational checking of the intra-aortic balloon pump (iabp) (battery- operated) at the distributor's site, after about 60 minutes, a "large helium leak" alarm and "high base line" alarm occurred.
 
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Brand Name
AUTOCAT2 WAVE JAPANESE
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key11706599
MDR Text Key262882702
Report Number3010532612-2021-00099
Device Sequence Number1
Product Code DSP
UDI-Device Identifier30801902043420
UDI-Public30801902043420
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,foreig
Type of Report Initial,Followup
Report Date 03/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN000325
Device Catalogue NumberIAP-0500J
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2021
Date Manufacturer Received06/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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