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 Incomplete or Inadequate Connection (4037)

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

Event Date 10/31/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during routine check, the cardiosave intra-aortic balloon pump (iabp) unit will not turn on.

Manufacturer Narrative

Updated fields: b4,d9,e1(site country),g3,g6,h2,h3,h4,h6(type of investigation, investigation findings, component codes, investigation conclusions),h10,h11.Corrected fields: h6(health effect ¿ clinical code, health effect ¿ impact codes).It was reported that the cardiosave intra-aortic balloon pump (iabp) unit was not turning on.A getinge field service engineer (fse) confirmed issue and stated customer¿s unit will not power on.To resolve issue replaced power management board.Completed pm with full calibration, functional testing, and safety check to factory specifications.Unit passed all functional and safety tests per factory specifications, returned to customer, and cleared for clinical use.There was no patient involvement.The defective components were received for further investigation.The power management board part was observed per the cardiosave service manual with visual damage.The failure analysis and testing dept.Could not install the power management board into the cardiosave test fixture and tested the power management board to factory specifications per procedure and the cardiosave service manual.Physical damage from fluid ingress caused the board to be inoperable.Power management board was held in the fat dept.As per procedure number 0002-07-d008 revision ak.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to define.

• 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: 15853681
• MDR Text Key: 307081909
• Report Number: 2249723-2022-03011
• 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
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.