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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AC3 OPTIMUS IAB PUMP SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL LLC AC3 OPTIMUS IAB PUMP SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN001112
Device Problem Gas Leak (2946)
Patient Problem Insufficient Information (4580)
Event Date 03/07/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4). There is an investigation ongoing into this reported complaint. A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.
 
Event Description
It was reported that the pump alarmed helium leak during use. As a result, the pcs was replaced. There are no information available on the patient. If additional information is received at a later date the complaint file will be updated.
 
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Brand NameAC3 OPTIMUS IAB PUMP
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
kaylia pen
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key14055430
MDR Text Key289001788
Report Number3010532612-2022-00112
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K162820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2022
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
Date Manufacturer Received04/29/2022
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 Unkown

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