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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT 2 SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. AUTOCAT 2 SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000302
Device Problems Mechanical Problem (1384); Pumping Stopped (1503)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/28/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon pump alarmed for "system error 3, and the pneumatic system stop pumping during the procedure". As a result, staff press the start button again and pump come back to work. There was no report of delay in therapy. There was a report of delay in therapy. There was no report of patient complications, serious injury or death.
 
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Brand NameAUTOCAT 2
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
jonathan kimchan
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key9903402
MDR Text Key185961504
Report Number3010532612-2020-00086
Device Sequence Number1
Product Code DSP
UDI-Device Identifier30801902051722
UDI-Public30801902051722
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN000302
Device Catalogue NumberIAP-0400
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 Received04/30/2020
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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