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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
Model Number IPN001112
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/30/2019
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4). Teleflex reassessed the information contained in this complaint and determined that it should have been submitted to fda as a 30-day report in accordance with 21 cfr part 803. This report is being submitted as a combined initial 30-day and follow up to include our investigation findings. Teleflex investigation findings: teleflex received the device for investigation. The reported complaint of piezo alarm was confirmed by the field service agent and through the investigation of (b)(4). The returned m-force motor driver assembly passed visual and functional test specifications during the complaint investigation. The root cause of the complaint 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
It was reported by the field service engineer (fse) that during a routine check it was found that the intra-aortic balloon pump (iabp) will not pump. There was no patient involvement. It was noted that after boot-up complete, piezo alarm is energized. As a result, fse replaced the m-force driver, there is no longer a piezo alarm and the iabp is pumping normal. There is no report of patient consequence.
 
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Brand NameAC3 OPTIMUS IABP NA/EMEA
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
kaylia pen
2400 bernville road
reading, PA 19605
MDR Report Key11961223
MDR Text Key263153001
Report Number3010532612-2021-00175
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 10/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN001112
Device Catalogue NumberIAP-0700
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2020
Was Device Evaluated by Manufacturer? Yes
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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