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 Run on Battery (1466)

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

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: a getinge field service engineer (fse) from the dealer, evaluated this unit and reported that after the device is unplugged from the ac, it cannot be switched to battery power supply.If it is directly powered on by the battery, the condition is normal.The initial judgment is that the ac/dc conversion function is abnormal due to the power manager pcb failure.The service engineer ordered the parts because the spare parts are currently reserved.The unit will be fix after new parts are received.Additionally, the service engineer reported that unit is not able to detect the battery and by his judgement, the battery is at faulty and it needs replacement as well.Service was not completed.Upon completion of our investigation, a supplemental report will be submitted.The full name of the event site was shortened due to field character limit; the full name is: (b)(6) hospital.

Event Description

It was reported that before use and when unplugging the cardiosave intra-aortic balloon pump (iabp) from the ac power, the battery will be abnormal.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The getinge field service engineer (fse) received the order parts and completed the repair by replacing the batteries and the power management pcb board.All functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.

Event Description

N/a.

Manufacturer Narrative

Updated fields: e1 (site country), h6 (type of investigation, investigation findings, investigation conclusion, component code).

Event Description

N/a.

• 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: 12142774
• MDR Text Key: 260706597
• Report Number: 2249723-2021-01466
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: N/A.