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

Model Number 0998-00-0800-52

Device Problems Failure to Power Up (1476); Appropriate Term/Code Not Available (3191)

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

Event Date 08/14/2023

Event Type  malfunction  

Event Description

It was reported that during an unrelated service being performed by a getinge field service engineer (gfse), the cardiosave intra-aortic balloon pump (iabp) unit was unable to power up, error code 58 and 124 were found in the log, x2 and x3 transducer displayed no value, and unable to perform 30 psi cal and drive regulator cal.There was no patient involvement.

Manufacturer Narrative

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

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h4, h6(investigation type, investigation findings, component codes & investigation conclusions), h10.The getinge field service engineer (fse) that encountered the issue replaced the front end board.Normal start up to clinical mode, unable to boot to clinical mode startup to special mode, unable to perform 30psi cal and drive regulator cal also suspect drive and vacuum transducer faulty (x2 and x3).Replaced drive manifold (0104-00-0032), drive and vacuum transducer (0682-00-0091-01) unit unable to perform calibration and failed to start up clinical mode.Did a thorough check on main boards, pneumatic assembly (continuity and visual check) found 2 pins on j19 port of backplane board shorted together replaced backplane board (0670-00-1163).Unit able to startup to clinical mode, performed system calibrations, performance checks and endurance run on clinical mode unit tested pass factory specification.The maquet failure analysis and testing (fat) department received the following parts associated with this complaint: pn: 0670-00-0768, sn: (b)(6) backplane board.Pn: 0104-00-0031, sn: (b)(6) manifold assy, pn: 0682-00-0091-01, sn: (b)(6) pressure transducer.Pn: 0682-00-0091-01, sn: (b)(6) pressure transducer.These parts were received with a reported unit failure message of unit unable to power up, error codes 54 and 124, unable to performed 30psi cal, unit unable to perform calibration, failed to start up clinical mode, backplane board j19 connector 2pins shorted.Performed visual inspection of these parts received and all parts looks be in good condition.Installed all parts into the cardiosave test fixture and tested together and separately to the factory specifications and the cardiosave service manual.Cardiosave test fixture was worked correctly after installed all complaint parts.The failure analysis and testing department could not verify the failure message of unit unable to power up, error codes 54 and 124, unable to performed 30psi cal, unit unable to perform calibration, failed to start up clinical mode, backplane board j19 connector 2pins shorted.All complaint parts passed testing.Retaining all parts in the fat dept, as per procedure.Due to non-rohs pn: 0670-00-0768, sn: (b)(6) backplane board, this part is not going back to supplier for further investigation.

• Brand Name: CARDIOSAVE HYBRID, TYPE G 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: 19129959
• MDR Text Key: 340942580
• Report Number: 2249723-2024-01572
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108438
• UDI-Public: 10607567108438
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-52
• Device Catalogue Number: 0998-00-0800-52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2023
• Date Manufacturer Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1