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

Model Number 0998-00-0800-31

Device Problem Break (1069)

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

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during unrelated servicing by a getinge service engineer, the cardiosave intra-aortic balloon pump (iabp) unit failed ppm; coiled cable was damaged/ one pin was out.No patient was involved.

Event Description

N/a.

Manufacturer Narrative

Info from (b)(6) 2024 indicates getinge service engineer discovered failure during a recall (coiled cable) was damaged/ one pin was out, no patient was involved and additional customer info received.Jd (b)(6) 2024 additional information: e1(event site telephone:(b)(6) it was reported that cardiosave intra-aortic balloon pump (iabp).A getinge field service engineer (fse) attended the site and located the unit to be repaired, dismantled the unit and re-fitted new cable pneu-mod to the backplane board.Fse reassembled the unit and performed all safety checks on the system as per getinge specifications.Excessive leak through the system was detected/reopen the unit to investigate, the fault was rectified and reassembled the unit and the system was returned back to service fully functional.Note unit require new safety disc see spt test results for more details.Scroll compressor and drive regulators replaced as per ivons request safety disc replaced.Completed full functional check of device.Adjusted and checked drive regulator pressures, all ok.Re-calibrated 30 psi pressure transducer.Compressor test completed - passed.Helium regulator check -passed.All manifolds test - passed.Helium leak test - passed.Checked drive regulator pressures - all ok.Adjusted time and date.Est completed.Checked and extracted error logs, all ok.Balloon pump cleared for clinical use.No patient involvement.

• Brand Name: CARDIOSAVE HYBRID TYPE I (AU)
• 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: 18764612
• MDR Text Key: 336182026
• Report Number: 2249723-2024-00779
• Device Sequence Number: 1
• Product Code: DSP
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• 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
• Date Manufacturer Received: 02/14/2024
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1