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 Circuit Failure (1089)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/25/2023

Event Type  Death  

Event Description

It was reported that during system inspection the cardiosave intra-aortic balloon pump (iabp) it was discovered that units executive process board needs replacement.

Manufacturer Narrative

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

Manufacturer Narrative

Corrected sections: b1,b2,b5,h6(clinical & impact).

Event Description

It was reported that during system inspection the cardiosave intra-aortic balloon pump (iabp) it was discovered that units executive process board needed replacement.It was later reported that patient death occurred.Related balloon complaint: (b)(4), mfg report # : 2248146-2023-00146.

Event Description

N/a.

Manufacturer Narrative

The customer indicated that a collaborative assessment was to be performed by an getinge field service engineer(fse) alongside an independent 3rd -party company who will be a representative for the hospital.The unit is still sequestered and has not been evaluated yet.When the unit becomes available for evaluation and is evaluated, a supplemental report will be submitted.

• 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: 16410450
• MDR Text Key: 309958824
• Report Number: 2249723-2023-01195
• 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: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 02/21/2023
• Supplement Dates Manufacturer Received: 02/09/2023; 10/05/2023
• Supplement Dates FDA Received: 03/03/2023; 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Death