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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 04/03/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the screen (display) on the intra-aortic balloon pump (iabp) was not usable.As a result, staff switched to a 2nd pump.Field service engineer replaced the display and pump passed all functional testing.There was no report of patient complications.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of iabp touch screen display error is not confirmed.The field service engineer could not duplicate the issue, and the display head returned to teleflex chelmsford for investigation passed visual and functional test specifications.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.No further action required.
 
Event Description
It was reported that the screen (display) on the intra-aortic balloon pump (iabp) was not usable.As a result, staff switched to a 2nd pump.Field service engineer replaced the display and pump passed all functional testing.There was no report of patient complications.
 
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Brand Name
AC3 OPTIMUS IABP NA/EMEA
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8557318
MDR Text Key143557148
Report Number3010532612-2019-00115
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902084965
UDI-Public00801902084965
Combination Product (y/n)N
PMA/PMN Number
K162820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIAP-0700
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2019
Date Manufacturer Received05/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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