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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.
 
Manufacturer Narrative
Qn# (b)(4).Teleflex received the device for investigation, after careful inspection it was determined that this is a non-teleflex battery.No functional testing will be performed.The reported complaint of iabp shut off during transport is confirmed by a teleflex field service engineer.A loose cable connection in the power switch assembly was noted and repaired by a field service engineer.The battery was replaced as a precaution.The root cause of this complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This will be monitored for any developing trends.No further action required at this time.
 
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 Name
AUTOCAT2 WAVE
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8882880
MDR Text Key153976419
Report Number3010532612-2019-00258
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/19/2019
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Catalogue NumberIAP-0500
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2019
Date Manufacturer Received09/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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