MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-55

Device Problems Overheating of Device (1437); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 04/19/2024

Event Type  malfunction  

Event Description

It was reported that during patient use, the cardiosave intra-aortic balloon pump (iabp) system was overheating and crashed several times with a notification on the monitor.

Manufacturer Narrative

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

Event Description

It was reported that during patient use, the cardiosave intra-aortic balloon pump (iabp) system was overheating and crashed several times with a notification on the monitor.There was no damage to operators/patients.

Event Description

It was reported that during routine check test phase with a test catheter, the cardiosave intra-aortic balloon pump (iabp) system was overheating and crashed several times with a notification on the monitor.There was no patient involved.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that they were able to confirm the issue.The fse replaced the compressor, filters, 9v battery, and o-ring.The unit passed all functional and safety tests and the unit was returned to customer.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID W/ E/F 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: 19217041
• MDR Text Key: 341467430
• Report Number: 2249723-2024-01776
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• Date Manufacturer Received: 04/19/2024
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1