MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE HYBRID TYPE I (AU); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-31

Device Problem Communication or Transmission Problem (2896)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during maintenance the cardiosave intra-aortic balloon pump (iabp) had a failed internal communication.

Event Description

It was reported that during maintenance the cardiosave intra-aortic balloon pump (iabp) had a failed internal communication.There was no patient involvement.

Manufacturer Narrative

Updated fields - b4,d9,e1(event site postal code - 6008),g3,g6,h2,h3,h4,h6(type of investigation,investigation findings,component code,investigation conclusions),h10,h11.Corrected field - d5,e1(initial reporter,event site email),e2,e3,g2.Additional contact information - (b)(6).A getinge field service engineer (fse) evaluated and replaced pcba, exec processor and pcba, video generator to fix the issue.Fse reloaded software version d.00, tested the unit to (b)(6) and getinge specification.Performed all safety and clinical checks as per getinge recommendation.Unit was returned back to service fully functional.

Event Description

N/a.

Manufacturer Narrative

Firm is providing updated device identification information in alignment with gudid.

• Brand Name: CARDIOSAVE HYBRID TYPE I (AU)
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 18221268
• MDR Text Key: 329347259
• Report Number: 2249723-2023-05059
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567109053
• UDI-Public: (01)10607567109053(21)CB351300D2
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/25/2024

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: Other
• Device Model Number: 0998-00-0800-31
• Device Catalogue Number: 0998-00-0800-31
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 11/29/2023; 04/02/2024; 09/25/2024
• Supplement Dates FDA Received: 12/01/2023; 04/03/2024; 10/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1