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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during preventive maintenance/testing, the cardiosave intra-aortic balloon pump (iabp) low level connector pins were found to be broken at pcb.There was no patient involvement reported.

Event Description

N/a.

Manufacturer Narrative

Additional customer contact details: name: (b)(6).A getinge field service engineer (fse) found that a couple pins for the low level connector were broken on the front end board.Fse replaced the board (pcb,front end,rohs, pcba, exec processor and kit, display monitor to video gen board).Then fse completed all diagnostic calibrations and tests.Fse powered the unit down and started to complete the performance tests.The unit would no boot back up.He tried to reinstall the b.17 software but the executive processor board would not accept the install and then replaced the executive processor board and was able to install the b.17 software.The unit display still would not start up.Fse installed the video generator board to display kit and then he was able to finally restart the unit and completed all diagnostic, performance and safety tests.The unit was then approved for clinical use and returned to the department.The executive processor board and video generator kit are not being charged for because this could have been from the coiled cable service.Pm service order, 44564463, with checklist attached.The defective components were received for further investigation.These parts were received with a reported failure of not booting up properly.The fat performed a visual inspection and found the part to be in good condition.The fat installed the pcba, exec processor in cardiosave test fixture and tested the part to factory specifications per the cardiosave service manual part number 0070-00-0639 revision r.Confirmed this part would not boot up properly.The fat installed kit, display monitor to video gen board in cardiosave test fixture and tested the parts to factory specifications per the cardiosave service manual part number 0070-00-0639 revision r.Confirmed it would not boot up properly.Verified the reported failures but no root cause identified.Parts are obsolete and no longer able to be tested by supplier.Retaining the part in the failure analysis and testing department per procedure number 0002-07-d008 rev.Aq.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: 18544766
• MDR Text Key: 333264885
• Report Number: 2249723-2024-00263
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Date Manufacturer Received: 01/10/2024
• Date Device Manufactured: 08/27/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1