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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/02/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
There was no patient involvement.It was reported that during product training/demonstration, the alarm of system error 3 went off after pumping started.The user tried to restart the pumping by turning off and on the main power switch; however, the same alarm went off immediately.The alarm went off about 5 times in the end.A technical specialist is scheduled to visit the facility for inspection of the intra-aortic balloon pump (iabp).
 
Manufacturer Narrative
Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of "system error 3 alarm" is confirmed.A loose connector pin on the output cable of the m-force was noted and caused the alarms.The root cause of the complaint is undetermined.A non-conformance has been initiated to further investigate the issue.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.
 
Event Description
There was no patient involvement.It was reported that during product training/demonstration, the alarm of system error 3 went off after pumping started.The user tried to restart the pumping by turning off and on the main power switch; however, the same alarm went off immediately.The alarm went off about 5 times in the end.A technical specialist is scheduled to visit the facility for inspection of the intra-aortic balloon pump (iabp).
 
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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 Key12091787
MDR Text Key259143457
Report Number3010532612-2021-00170
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,distri
Type of Report Initial,Followup
Report Date 06/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
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 Manufacturer06/22/2021
Date Manufacturer Received07/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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