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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/EMEA SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/EMEA SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0700
Device Problems Erratic or Intermittent Display (1182); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/01/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the field engineer that on the intra-aortic balloon pump (iabp) a weird display screen appears. The electrocardiogram (ecg) and pressure freezes, and gas icon and battery icon go to red x. As a result, the cpm board was replaced. There was no reported patient injury or consequence.
 
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Brand NameAC3 OPTIMUS IABP NA/EMEA
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 Key9087964
MDR Text Key159317052
Report Number3010532612-2019-00360
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeTC
PMA/PMN Number
K162820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 08/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0700
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2020
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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