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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 IAP-0500
Device Problems Failure To Run On AC/DC (1001); Low Battery (2584)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/03/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that after inserted of the catheter and connected with the intra-aortic balloon pump (iabp), the pump did not switch on.The technician found low battery of the pump and disconnection from ac/dc power supply.The pump was switched out with no complications.No other issues found, the pump is working at the final test.There was no patient death, serious injury or patient complication reported.
 
Event Description
It was reported that after inserted of the catheter and connected with the intra-aortic balloon pump (iabp), the pump did not switch on.The technician found low battery of the pump and disconnection from ac/dc power supply.The pump was switched out with no complications.No other issues found, the pump is working at the final test.There was no patient death, serious injury or patient complication reported.
 
Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation.The reported complaint of "low battery alarm" was confirmed by the field service technician.The field service technician noted the ac/dc cable connection on power supply was disconnected/loosen which caused a low battery alarm.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.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 Key7475383
MDR Text Key106974969
Report Number3010532612-2018-00103
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,foreig
Type of Report Initial,Followup
Report Date 04/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIAP-0500
Device Catalogue NumberIAP-0500
Other Device ID Number00801902051714
Was Device Available for Evaluation? No
Date Manufacturer Received05/31/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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