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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.
 
Manufacturer Narrative
Qn#(b)(4).This complaint is a duplicate of previously reported complaint (eleflex arrow ref.(b)(4) mdr #3010532612-2019-00144, therefore, this complaint teleflex arrow ref.#(b)(4) will be closed/canceled.The investigation findings will be submitted in complaint teleflex arrow ref.(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 Name
AC3 OPTIMUS IABP NA/EMEA
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8633828
MDR Text Key145907701
Report Number3010532612-2019-00148
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 05/02/2019
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Catalogue NumberIAP-0700
Was Device Available for Evaluation? No
Date Manufacturer Received05/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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