MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AC3 IABP NA/AJLA; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAP-0601

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  malfunction  

Event Description

It was reported " the power suppl is interrupted during use, unable to tun on the power and a long alarm sounds.".This issue did not occur during use on a patient.No patient involvement.

Manufacturer Narrative

(b)(4).

Event Description

It was reported "the power suppl is interrupted during use, unable to tun on the power and a long alarm sounds".This issue did not occur during use on a patient.No patient involvement.

Manufacturer Narrative

Qn# (b)(4).The reported complaint of "unable to turn on the power, and a long alarm sound" is not able to be confirmed.No part was 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.Iabp users and servicers must follow the operating instructions manual for recommendations on usage, charging, maintenance and storage of the batteries.If battery maintenance is not performed per the iabp operating instructions manual, the battery may not provide the expected minimum run time of operating power.

• Brand Name: AC3 IABP NA/AJLA
• Type of Device: 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: taliah shabazz ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19052249
• MDR Text Key: 339559095
• Report Number: 3010532612-2024-00252
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10801902172096
• UDI-Public: 10801902172096
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: IAP-0601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1