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

Model Number 0998-00-0800-53 - CARDIOSAVE HYBRID DOMESTIC

Device Problem Unexpected Shutdown (4019)

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

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

Device not accessible for testing: at this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested from the customer with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) shut off.The end user noticed the iabp was plugged into the hospital bed outlet so the unit was unplugged to move it over to a red plug.After unplugging, the screen ¿turned blue.¿ the end user then plugged it back into a red outlet and it turned back on without issue.The customer reviewed the necessity of using a red outlet as well as how to check to be sure the battery is in fact charging.As a precaution, the end user swapped out the iabp unit with another iabp unit to continue therapy without issue.The suspected faulty iabp unit was tagged for the customer's biomed.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

At this time, the customer has not requested getinge to evaluate the iabp.Additional information was requested from the customer with regard to the repair and status of the iabp, and no repair information nor status of the iabp has been received; however, a getinge field service engineer (fse) was dispatched to the customer's site to performed a schedule preventative maintenance (pm) and completed the pm with all calibrations, functional and safety checks to meet factory specifications.Unit passed all calibrations, functional and safety test per factory specifications.The iabp was then released and cleared for clinical service.Service not requested.

Manufacturer Narrative

Updated sections: b4, e1(event site email), g3, g6, h2, h10.

Event Description

N/a.

• Brand Name: CARDIOSAVE
• 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: 12389477
• MDR Text Key: 268917289
• Report Number: 2249723-2021-01960
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2024

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 Operator: Health Professional
• Device Model Number: 0998-00-0800-53 - CARDIOSAVE HYBRID DOMESTIC
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/30/2021
• Supplement Dates Manufacturer Received: 09/23/2021; 01/24/2024
• Supplement Dates FDA Received: 02/08/2024; 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 102 KG