MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AUTOCAT2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN000320
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, "error detected by hospital service engineers during check.'system running on battery' alarm when switched on even if connected to the main; green led doesn't switch on power supply failure".No patient involvement.
Additional Manufacturer Narrative
(b)(4) returned for investigation was a condor power supply.The sample was returned in a brown cardboard box with protective shipping packaging.Visual inspection of the power supply was performed and no abnormality was noted.The power supply was installed into a known good ac2 for functional testing.The pump powered up successfully; however, the ac power was not detected and issued "system running on battery power".The iabp was run on battery until the iabp shut down.The battery was then left to charge in the iabp for over 9 hours.The power supply voltage check was performed per ac2 series service manual and all output voltages were not present along with blank screen on power-up.An examination of the device history record (dhr) could not be completed because the dhr information was unavailable, but the service history information was reviewed for the reported complaint.There were no problems identified during the review of the service history for this device.The reported complaint of "power supply failure" is confirmed.The system failed to power-up after fully discharging the battery and no voltage outputs were present.The specifications were not met during the complaint investigation due to no output voltages.The root cause of the power supply voltage output failure is undetermined.No further action required at this time.This will be monitored for any developing trends.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that, "error detected by hospital service engineers during check.'system running on battery' alarm when switched on even if connected to the main; green led doesn't switch on power supply failure".No patient involvement.

• Brand Name: AUTOCAT2 WAVE
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17749481
• Report Number: 3010532612-2023-00539
• Device Sequence Number: 4085590
• Product Code: DSP
• UDI-Device Identifier: 30801902051715
• UDI-Public: 30801902051715
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K060309
• 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): 09/05/2023

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 Model Number: IPN000320
• Device Catalogue Number: IAP-0500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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