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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AC3 OPTIMUS IABP NA/AJLA; System, balloon, intra-aortic and control
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ARROW INTERNATIONAL LLC AC3 OPTIMUS IABP NA/AJLA; System, balloon, intra-aortic and control Back to Search Results
Model Number IPN917286
Device Problem Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/04/2019
Event Type  malfunction  
Event Description
The report states that "the iabp system restarts automatically.Origin of failure unknown, the system works normal after restarting a few times".Additional information states that the event occurred prior to use on patient with no patient involvement.Associated mdrs; 3010532612-2022-00413, 3010532612-2022-00429, 3010532612-2022-00416, 3010532612-2022-00419, and 3010532612-2022-00417.
 
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
The report states that "the iabp system restarts automatically.Origin of failure unknown, the system works normal after restarting a few times".Additional information states that the event occurred prior to use on patient with no patient involvement.Associated mdrs; 3010532612-2022-00413, 3010532612-2022-00429, 3010532612-2022-00416, 3010532612-2022-00419, and 3010532612-2022-00417.
 
Manufacturer Narrative
(b)(4).The reported complaint of "system restart automatically" is not able to be confirmed.The product was not returned for investigation.According to the event details, the issue was resolved after the power cycle was completed a few times.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.
 
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Brand Name
AC3 OPTIMUS IABP NA/AJLA
Type of Device
System, balloon, intra-aortic and control
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
bryanna connelly
3015 carrington mill blvd
morrisville 27560
MDR Report Key15620799
MDR Text Key306911915
Report Number3010532612-2022-00418
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10801902172072
UDI-Public10801902172072
Combination Product (y/n)N
Reporter Country CodeSN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberIPN917286
Device Catalogue NumberIAP-0701
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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