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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0500
Device Problems Loose or Intermittent Connection (1371); Pumping Stopped (1503)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/19/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) shut down during a patient transport. Field service engineer (fse) found the complaint was actually an intermittent 20 seconds shutdown and automatic restart by itself and then seemed to be ok. As a result, fse tightened all the wiring connectors and eliminated the intermittent connection. The fse also replaced the battery. There was no report of patient complications, serious injury or death.
 
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Brand NameAUTOCAT2 WAVE
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
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key8882880
MDR Text Key153976419
Report Number3010532612-2019-00258
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 07/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2019
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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