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 Communication or Transmission Problem (2896)

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

Event Date 11/12/2021

Event Type  malfunction  

Event Description

It was reported that during an in house training performed by a getinge clinical representative that the cardiosave intra-aortic balloon pump (iabp) was noted to have an unresponsive touch screen.There was no patient involvement, and no adverse event was reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse replicated the user complaint.The screen was initially unresponsive on clinical mode.The screen only responded upon pressing screen firmly and with reasonable force.The fse was unable to zero the pressure nor access other clinical menus.The fse replaced suspect touch screen and the screen was responsive post replacement.The unit was calibrated and passed all functional and safety tests per factory specifications.The unit was returned to the customer and cleared for clinical use.A supplemental report will be submitted upon completion of our investigation.The initial reporter named is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6).

Manufacturer Narrative

Updated fields: b4, e1(site country), g3, g6, g7, h2, h4, h6(type of investigation, investigation findings and investigation conclusions), h10.The maquet national repair center (nrc) received the touchscreen assembly and observed per the cardiosave service manual with no visual damage.The national repair center installed the touchscreen assembly into the cardiosave test fixture and tested the touchscreen assembly to factory specifications per procedure number 0002-07-d016 revision c and the cardiosave service manual.No problem was found.Touchscreen assembly will be sent to the supplier for failure analysis per procedure number 0002-07-d008 revision ag.The non-conformances with the returned components were not confirmed.However, the root cause or the most probable root cause is not confirmed.Supplier not able to test this part any longer.Investigation is completed.Retaining the part in the failure analysis and testing department per procedure number 0002-07-d008 rev.Aq.

Event Description

N/a.

• 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: 12961529
• MDR Text Key: 286868057
• Report Number: 2249723-2021-02802
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• 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: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.