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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE
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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE Back to Search Results
Model Number IPN000320
Device Problem Charging Problem (2892)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/03/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
Prior to use on a patient during inspection/functional testing.It was reported that the iabp machine is not responding to external power supply, battery is not getting charged.Suspecting power supply failure.
 
Manufacturer Narrative
Qn# (b)(4).Teleflex received the device for investigation.The reported complaint of "unable to power-up" is confirmed.The pump displayed blank screen with no voltage outputs during testing.The root cause of the power supply voltage output failure is undetermined.A device history record (dhr) review was conducted for the lot number/serial 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 risk.This will be monitored for any developing trends.
 
Event Description
Prior to use on a patient during inspection/functional testing.It was reported that the iabp machine is not responding to external power supply, battery is not getting charged.Suspecting power supply failure.
 
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Brand Name
AUTOCAT2 WAVE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key12388436
MDR Text Key271232881
Report Number3010532612-2021-00261
Device Sequence Number1
Product Code DSP
UDI-Device Identifier30801902051715
UDI-Public30801902051715
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN000320
Device Catalogue NumberIAP-0500
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2021
Date Manufacturer Received09/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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