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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 No Display/Image (1183); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/21/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the touchscreen on the intra-aortic balloon pump (iabp) has been non-responsive the entire time that the pump has been on this patient in the cardiac intensive care unit (icu). The hard keys are still working, and they have been able to do their normal tasks without using the touchscreen. As a result, the pump was switched out for another iabp. There have been no delays in therapy at all, and no harm to the patient. There was no report of patient injury or consequence.
 
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint of iabp touch screen unresponsive is confirmed based on the photos provided in the complaint of recorder strips showing system error 7 alarms; however, the returned display head 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. This will be monitored for any developing trends. No further action required at this time.
 
Event Description
It was reported that the touchscreen on the intra-aortic balloon pump (iabp) has been non-responsive the entire time that the pump has been on this patient in the cardiac intensive care unit (icu). The hard keys are still working, and they have been able to do their normal tasks without using the touchscreen. As a result, the pump was switched out for another iabp. There have been no delays in therapy at all, and no harm to the patient. There was no report of 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
MDR Report Key8885113
MDR Text Key154024327
Report Number3010532612-2019-00257
Device Sequence Number1
Product Code DSP
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 07/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/12/2019
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 Manufacturer08/05/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2019
Is This a Reprocessed and Reused Single-Use Device? No

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