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 Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) units ecg adaptor is broken.It is unknown under which circumstances the issue was discovered or if there was any patient involvement.

Event Description

It was reported that during routine check, the cardiosave intra-aortic balloon pump (iabp) units ecg adaptor is broken.

Manufacturer Narrative

Updated field: b4, d9, e1-(site country), g3, g6, h2, h3, h4, h6(type of investigation, investigation findings, investigation conclusion, investigation conclusions),h10.It was reported that the cardiosave intra-aortic balloon pump (iabp) had a issue of ecg adaptor is broken and can't plug in.A getinge field service engineer evaluated the unit and confirmed - ecg ext plug is damaged.Possible obstruction or damaged pin socket won't allow the ecg cable to plug in.Fse replaced front end board.Re calibrated 30 psi and tested.Repair successful.Performed all functional tests and calibrated system.Note pm was due in september 2022.Pm was performed after repair was completed.For checklist see pm service report so# (b)(4) (attached).Cleared for clinical use.

Event Description

N/a.

• 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: 15236132
• MDR Text Key: 304899205
• Report Number: 2249723-2022-02090
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2024

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
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 08/16/2022
• Supplement Dates Manufacturer Received: 12/15/2022; 03/28/2024
• Supplement Dates FDA Received: 01/04/2023; 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2024
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.