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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 05/07/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the touchscreen on the intra-aortic balloon pump (iabp) would not respond with multiple attempts. The perfusionist was unable to access any of the functions on the touchscreen. The pump was able to initiate pumping with the hard keys. The patient was supported without issue. As a result, the pump was swapped out and sent to biomed. There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint of "touchscreen malfunction" cannot be confirmed. 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/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 reported complaint 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) would not respond with multiple attempts. The perfusionist was unable to access any of the functions on the touchscreen. The pump was able to initiate pumping with the hard keys. The patient was supported without issue. As a result, the pump was swapped out and sent to biomed. There was no report of patient complications, serious injury or 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 Key8653575
MDR Text Key146480507
Report Number3010532612-2019-00157
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 05/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/30/2019
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 Manufacturer05/15/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2019
Is This a Reprocessed and Reused Single-Use Device? No

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