MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AC3 OPTIMUS IABP NA/AJLA; System, balloon, intra-aortic and control

Model Number	IPN917286
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, "the display of ac3(190934f) appears abnormal signals during pumping on patient.First, the monitor's ecg and ap signals disappear (become noisy and flat) and hr shows 250 bpm but from the sound of pumping, the system seems functioning normally.Then, the battery and helium indicators appear "not ok" sign briefly.The engineer has checked the cable of ecg and ap and found nothing wrong.The user also confirmed the ac3 has been connected to main ac power source when it not used on patient.No further action was taken as the ac3 is still being used on the patient and the machine is currently functioning normally.Further inspections will be performed after the machine is off from the patient".Patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that, "the display of ac3(190934f) appears abnormal signals during pumping on patient.First, the monitor's ecg and ap signals disappear (become noisy and flat) and hr shows 250 bpm but from the sound of pumping, the system seems functioning normally.Then, the battery and helium indicators appear "not ok" sign briefly.The engineer has checked the cable of ecg and ap and found nothing wrong.The user also confirmed the ac3 has been connected to main ac power source when it not used on patient.No further action was taken as the ac3 is still being used on the patient and the machine is currently functioning normally.Further inspections will be performed after the machine is off from the patient".Patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Upon further review from the quality engineers, it was found that the malfunction was not reportable; thus the initial mdr, submitted on 21 feb 2023, should be retracted.Other remarks: n/a.Corrected data: upon further review from the quality engineers, it was found that the malfunction was not reportable; thus the initial mdr, submitted on 21 feb 2023, should be retracted.

• Brand Name: AC3 OPTIMUS IABP NA/AJLA
• Common Device Name: System, balloon, intra-aortic and control
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16411018
• Report Number: 3010532612-2023-00127
• Device Sequence Number: 20174063
• Product Code: DSP
• UDI-Device Identifier: 10801902172072
• UDI-Public: 10801902172072
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2020
• Device Model Number: IPN917286
• Device Catalogue Number: IAP-0701
• Device Lot Number: 190934F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown