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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 Problem Low Battery (2584)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/20/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that after catheter insertion the user powered on the intra-aortic balloon pump (iabp) and switched from ac to battery but, suddenly the display blacked out and the iabp system powered downed, (the iabp stopped working). The iabp was replaced by a backup device in the hospital, and the therapy was continued without problem. There was no reported of death, serious injury or complications to the patient.
 
Manufacturer Narrative
Qn# (b)(4). Teleflex received the device for investigation. The reported complaint of "the pump shut off on battery power" is not confirmed. The returned device passed both visual and functional test specifications. The root cause of the complaint is undetermined. Per operator's manual "the battery should be maintained at full charge whenever possible. Arrow international recommends that the autocat2 series iabp be kept plugged into a proper ac receptacle whenever possible including time when the unit is in storage or not in use. The power indicator will illuminate when ac power is present. The batteries should not be stored in a discharged state. " no further action required.
 
Event Description
It was reported that after catheter insertion the user powered on the intra-aortic balloon pump (iabp) and switched from ac to battery but, suddenly the display blacked out and the iabp system powered downed, (the iabp stopped working). The iabp was replaced by a backup device in the hospital, and the therapy was continued without problem. There was no reported of death, serious injury or complications to the patient.
 
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Brand NameAUTOCAT2 WAVE JAPANESE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key7458454
MDR Text Key106649244
Report Number3010532612-2018-00091
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500J
Other Device ID Number00801902043429
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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