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

Model Number 0998-00-0800-45

Device Problem Electrical /Electronic Property Problem (1198)

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

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 during power up, the cardiosave intra-aortic balloon pump (iabp) unit failed electrical test #4.There was no patient involvement.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, d9(device available for eval), g3, g6, h2, h3, h4, h6(investigation type, investigation findings & investigation conclusions), h10 a getinge field service engineer (fse) was dispatched to investigate the issue.In order to fix the issue, the fse performed a 30 psi pressure transducer calibration.After doing so, the calibration passed and the unit was able to start up and run normally.The fse performed all functional and safety checks to factory specifications.The unit was returned to the customer and cleared for clinical use.

• Brand Name: CARDIOSAVE HYBRID, TYPE I 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: 15248878
• MDR Text Key: 305171180
• Report Number: 2249723-2022-02096
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108421
• UDI-Public: 10607567108421
• 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
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

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: 0998-00-0800-45
• Device Catalogue Number: 0998-00-0800-45
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 06/05/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1