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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 09/24/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) when in use, the staff noted that the display was "distorted, nonresponsive to touch, and intermittent". As a result, the pump was switched out quickly. There was no report of patient complication or serious injury and death.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) when in use, the staff noted that the display was "distorted, nonresponsive to touch, and intermittent". As a result, the pump was switched out quickly. There was no report of patient complication or serious injury and death.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of "touchscreen unresponsive" is not able to be confirmed. The field service engineer could not duplicate the issue. The root cause of the complaint is undetermined. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. Teleflex assessed the risk for the reported complaint. There are no new or revised risks. The complaint will be monitored for any developing trends. No further action required at this time.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of "touchscreen unresponsive" is not able to be confirmed. The field service engineer could duplicate the issue. The root cause of the complaint is undetermined. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. Teleflex assessed the risk for the reported complaint. There are no new or revised risks. The complaint will be monitored for any developing trends. No further action required at this time.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) when in use, the staff noted that the display was "distorted, nonresponsive to touch, and intermittent". As a result, the pump was switched out quickly. There was no report of patient complication or serious injury and death.
 
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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 Key7978584
MDR Text Key124130105
Report Number3010532612-2018-00319
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,Followup
Report Date 09/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2018
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2018
Is This a Reprocessed and Reused Single-Use Device? No

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