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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CARDIAC UNKNOWN DUMMY MATERIAL

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ARROW INTERNATIONAL INC. CARDIAC UNKNOWN DUMMY MATERIAL Back to Search Results
Catalog Number CARDIAC UNKNOWN
Device Problem Inflation Problem (1310)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Complaint was received via the berman & wedge survey negative responses. It was reported that the balloon does not open symmetrically.
 
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Brand NameCARDIAC UNKNOWN DUMMY MATERIAL
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 Key10959438
MDR Text Key220656634
Report Number3010532612-2020-00369
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCARDIAC UNKNOWN
Device Lot NumberUNKNOWN
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 Received12/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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