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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 Power Problem (3010); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/06/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during inspection/functional testing , prior to use on a patient, the intra-aortic balloon pump (iabp) was switched on there was an alarming sound and the power was not on. By pulling out and re-inserting the ac cord, the power was turned on, but the user had decided to stop using the iabp. It was noted that the ac cord was connected to the iabp, however, it was not known if the power was properly supplied. Additional information received. According to the report, there was no other iabp available for use at that time, however, the hospital staff was able to complete the treatment of the patient only by drug administration. There was no report of delay in therapy. There was no report of patient complications, serious injury or death.
 
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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 Key9252131
MDR Text Key183741537
Report Number3010532612-2019-00387
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
Type of Report Initial,Followup
Report Date 10/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2019
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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