MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AUTOCAT 2; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAP-0400
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during transport, it was found that the machine battery did not supply power.After the patient is transferred to the ward, iabp uses ac power to continue auxiliary support.There was no report of patient complications, serious injury or death".Patient condition reported as "fine".
Event or Problem Description
It was reported that "during transport, it was found that the machine battery did not supply power.After the patient is transferred to the ward, iabp uses ac power to continue auxiliary support.There was no report of patient complications, serious injury or death".Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of "machine battery did not supply power" is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.
Event or Problem Description
It was reported that "during transport, it was found that the machine battery did not supply power.After the patient is transferred to the ward, iabp uses ac power to continue auxiliary support.There was no report of patient complications, serious injury or death".Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint of "machine battery did not supply power" is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.Other remarks: corrected data: additional information received: patient age, gender, and weight was added to section a.It was reported that "the patient's hemodynamics were unstable and blood pressure fluctuated".Upon arrival "at the ward, the equipment was connected to ac power and started to work, the patient's hemodynamics were stable, no medical intervention required".

• Brand Name: AUTOCAT 2
• 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: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15127110
• Report Number: 3010532612-2022-00274
• Device Sequence Number: 6603648
• Product Code: DSP
• UDI-Device Identifier: 00801902051721
• UDI-Public: 00801902051721
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2022

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 Catalogue Number: IAP-0400
• Device Lot Number: N/A
• 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: 07/01/2022
• Supplement Date Received by Manufacturer: 08/19/2022; 08/19/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 08/26/2022; 09/09/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED; NONE REPORTED
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 75 KG