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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 No Device Output (1435); Unable to Obtain Readings (1516)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/18/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Other remarks: see mdr# 3010532612-2019-00437 and (b)(4) as the report is related to the same patient.
 
Event Description
It was reported the intra-aortic balloon pump (iabp) ap and ecg signal were not present while in use.The display led's were flashing and there were alarms but it was not recorded.As a result, the pump was swapped out.There was no report of patient complications serious injury or death.The field service engineer (fse) serviced the iabp and could not replicate the problem, the iabp ran perfectly.
 
Manufacturer Narrative
Qn#: (b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of ap signal not present is not able to be confirmed.A teleflex field service agent serviced the pump and could not duplicate the reported complaint.The root cause of the 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 revived risk.This will be monitored for any developing trends.Other remarks: see mdr# 3010532612-2019-00437 and (b)(4) as the report is related to the same patient.
 
Event Description
It was reported the intra-aortic balloon pump (iabp) ap and ecg signal were not present while in use.The display led's were flashing and there were alarms but it was not recorded.As a result, the pump was swapped out.There was no report of patient complications serious injury or death.The field service engineer (fse) serviced the iabp and could not replicate the problem, the iabp ran perfectly.
 
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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 Key9427811
MDR Text Key183761834
Report Number3010532612-2019-00436
Device Sequence Number1
Product Code DSP
UDI-Device Identifier30801902051715
UDI-Public30801902051715
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 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2019
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? No
Date Manufacturer Received01/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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