• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. IABP AUTOCAT 2 WAVE PUMP CONSOLE - ITALIAN SYSTEM, BALLOON, INTRA-AORTIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL INC. IABP AUTOCAT 2 WAVE PUMP CONSOLE - ITALIAN SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000324
Device Problem Power Problem (3010)
Patient Problem No Patient Involvement (2645)
Event Date 10/08/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Other remarks: the field service engineer (fse) serviced the iabp and found the power supply to be faulty. The power supply was replaced.
 
Event Description
There was no patient involvement. It was reported that the intra-aortic balloon pump (iabp) failed to switch on. As a result, a new iabp was used.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameIABP AUTOCAT 2 WAVE PUMP CONSOLE - ITALIAN
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
kaylia pen
2400 bernville road
reading, PA 19605
MDR Report Key10750158
MDR Text Key213664288
Report Number3010532612-2020-00315
Device Sequence Number1
Product Code DSP
UDI-Device Identifier30801902092190
UDI-Public30801902092190
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 10/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN000324
Device Catalogue NumberIAP-0500I
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-