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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/EMEA; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/EMEA; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0700
Device Problems Erratic or Intermittent Display (1182); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) had a system error 7 alarm during use on a patient.The hard keys are working fine, and the waveforms all appear normal on the screen.The pump was power cycled and initially the touchscreen worked fine, but then some spots on the touchscreen was not working.The touchscreen was calibrated, but another system error 7 was received, and the touchscreen became inoperative again.As a result, the pump was swapped out.There was no report of patient complications, serious injury or death.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) had a system error 7 alarm during use on a patient.The hard keys are working fine, and the waveforms all appear normal on the screen.The pump was power cycled and initially the touchscreen worked fine, but then some spots on the touchscreen was not working.The touchscreen was calibrated, but another system error 7 was received, and the touchscreen became inoperative again.As a result, the pump was swapped out.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of system error 7 alarm was confirmed by a teleflex field service engineer.During service, the touchscreen became unresponsive after approximately 35 minutes of pumping.The display was replaced and sent to teleflex chelmsford for investigation.The returned display passed all visual and functional test specifications.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.No further action required at this time.
 
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Brand Name
AC3 OPTIMUS IABP NA/EMEA
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8974401
MDR Text Key156895754
Report Number3010532612-2019-00324
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K162820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIAP-0700
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2019
Initial Date Manufacturer Received 08/21/2019
Initial Date FDA Received09/09/2019
Supplement Dates Manufacturer Received10/18/2019
Supplement Dates FDA Received10/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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