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 Circuit Failure (1089)

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

Event Date 08/18/2022

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 (pm) performed by a getinge service territory manager (stm) the cardiosave intra-aortic balloon pump (iabp) touchscreen was not working.There was no patient involvement.

Manufacturer Narrative

Updated fields: e1 (site country), h6(type of investigation, investigation findings, component codes and investigation conclusions).Additional contact information: (name - (b)(6), occupation - biomed).A getinge field service engineer (fse) evaluated and replaced the video generator board and cleaned around the inside of the bezel/touchscreen which resolved the touchscreen issue.The unit passed all functional and safety tests to factory specifications.The unit was cleared for clinical use.The defective components were received for further investigation.Fat received parts and the video generator board kit was observed with no visual damage.Unable to calibrate touchscreen.The non-conformances with the returned components were not confirmed.However, the root cause is not confirmed.The video generator board was observed per the cardiosave service manual with no visual damage.Unable to calibrate touchscreen.Video generator board will be sent to the supplier for future failure analysis per procedure number (b)(4) revision aj.The non-conformances with the returned components were not confirmed.However, the root cause is not confirmed.The upper monitor video board was observed per the cardiosave service manual with no visual damage.The national repair center installed the upper monitor video board into the cardiosave test fixture and tested the upper monitor video board to factory specifications per procedure number (b)(4) revision c and the cardiosave service manual.Unable to calibrate touchscreen.Upper monitor video board will be sent to the supplier for future failure analysis per procedure number (b)(4) revision aj.The non-conformances with the returned components were not confirmed.However, the root cause is not confirmed.The video generator board observed per the cardiosave service manual with no visual damage.The national repair center installed the video generator board and tested the video generator board to factory specifications per procedure number (b)(4) revision c and the cardiosave service manual.No problem was found.Video generator board will be sent to the supplier for future failure analysis per procedure number (b)(4) revision aj.The new supplier (b)(4), will no longer accept (b)(4) boards back for failure analysis.Further failure analysis is not possible.The board will be scrapped per procedure number (b)(4) rev.Al.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.

• 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: 15323082
• MDR Text Key: 304812076
• Report Number: 2249723-2022-02216
• 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,Followup
• Report Date: 04/30/2024

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: Other
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1