MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-53

Device Problem Failure to Charge (1085)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that two of the batteries, for the cardiosave intra-aortic balloon pump (iabp) are having difficulty charging.The team was having an issue with seating correctly as one of our batteries wasn't charging at that time.They attempted removing the iabp and seating it again with no change.

Event Description

It was reported that during patient transport, two of the batteries, for the cardiosave intra-aortic balloon pump (iabp) are having difficulty charging.The team was having an issue with seating correctly as one of our batteries wasn't charging at that time.Unit was in transit for well over 1 hour when batteries did not switch.Unit is currently with the flight team at skyline medical center.They attempted removing the iabp and seating it again with no change.There was no patient injury.

Event Description

It was reported that post use, after the return flight from delivering a patient, two of the batteries, for the cardiosave intra-aortic balloon pump (iabp) are having difficulty charging.The team was having an issue with seating correctly as one of our batteries wasn't charging at that time.Unit was in transit for well over 1 hour when batteries did not switch.Unit is currently with the flight team at skyline medical center.They attempted removing the iabp and seating it again with no change.There was no patient involved.

• Brand Name: CARDIOSAVE HYBRID, TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 18238359
• MDR Text Key: 329381092
• Report Number: 2249723-2023-05086
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1