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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
Model Number IPN001112
Device Problems No Device Output (1435); Missing Test Results (3267)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/07/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the intra-aortic balloon pump (iabp) was not slaving the ecg from a non-teleflex monitor, as the monitor would not show a waveform. As a result, the iabp was swapped out. 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
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
jonathan kimchan
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key9636272
MDR Text Key183918898
Report Number3010532612-2020-00029
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN001112
Device Catalogue NumberIAP-0700
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2020
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 Unkown

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