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 Inability to Auto-Fill (1044); Failure to Run on Battery (1466); Detachment of Device or Device Component (2907)

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

Event Date 04/18/2023

Event Type  malfunction  

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit does not load.There was no patient harm reported.

Manufacturer Narrative

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

Manufacturer Narrative

Updated data: b4,g3,g6,h2,h10,h11 corrected data: b5,b6,b7,d10,e1(name),h6(impact).

Event Description

It was reported that before use, the cardiosave intra-aortic balloon pump (iabp) unit does not load.There was no patient involvement.

Event Description

It was reported that before use, the cardiosave intra-aortic balloon pump (iabp) unit does not load.The cardiosave does not charge although it is connected to the power supply.There was no patient involvement.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the iabp unit.The device was inspected by fse, troubleshooting revealed that the cardiosave was not properly locked in the sprinter.Cardiosave was locked in the chassy by the fse.The fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp was then released to the customer and cleared for clinical service.

• 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: 16845395
• MDR Text Key: 314308574
• Report Number: 2249723-2023-02120
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.; UNKNOWN.