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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
Catalog Number IAP-0500J
Device Problems No Display/Image (1183); Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/20/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) screen suddenly turned white and the device stopped working. The device was restarted but the same issue occurred. As a result, the device was replaced by a back-up and therapy continued without problem. There was no report of delay in therapy , patient complications or death.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of iabp "screen turned white suddenly" is not able to be confirmed. Additional information received indicates the pump was inspected by the distributor and the issue could not be duplicated. The root cause of the complaint is undetermined. A device history record (dhr) review was conducted for the lot 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.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) screen suddenly turned white and the device stopped working. The device was restarted but the same issue occurred. As a result, the device was replaced by a back-up and therapy continued without problem. There was no report of delay in therapy , patient complications or death.
 
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Brand NameAUTOCAT2 WAVE JAPANESE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8775212
MDR Text Key150549921
Report Number3010532612-2019-00208
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 06/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500J
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2019
Is This a Reprocessed and Reused Single-Use Device? No

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