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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 Problem Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/02/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the cath lab was attempting to place the intra-aortic balloon pump (iabp) on a patient. While the staff was doing the fiber optic sensor (fos) set, the display locked up (froze) and the staff was unable to complete the zero and change from fos source to monitor mode. As a result, the pump was swapped out. There was no report of patient complications, serious injury or death. The field service engineer (fse) service the pump. The iabp was powered down and back up to correct the symptom. The fse was unable to duplicate the symptom.
 
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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 Key8633828
MDR Text Key145907701
Report Number3010532612-2019-00148
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0700
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 Received05/02/2019
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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