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 No Display/Image (1183)

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

Event Date 08/29/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) unit screen display went blank.Therapy continued on the same device once the screen came back on.There was no patient injury or harm reported.

Manufacturer Narrative

Updated fields: d9(device available for eval, return to manufacture date), h6 (type of investigation, investigation findings, component codes and investigation conclusions).A getinge field service engineer (fse) evaluated and could not duplicate the reported issue of screen going blank during use.Fse found error code 118 close to reported date of event.Fse replaced video generator board.Unit passed all calibration, functional and safety tests performed.Unit was returned to customer and cleared for clinical use.The defective components were received for further investigation.The failure analysis and testing department received parts associated with this complaint, this part was received with a reported unit failure message of display went black while in use.Performed visual inspection of this part received and part looks to be in good condition.The failure analysis and testing department could not verify the failure of black display.The failure analysis and testing department performed all calibration tests and pumped the unit for 2 hours and did not observe any intermittent with display.Video gen.Board passed testing.Sending board to the supplier as per procedure 0002-07-d008 rev ap.The non-conformances with the returned components were not confirmed.Therefore, the root cause is not confirmed.The fat dept.Received part number video gen.Board from the supplier.The failure analysis and testing dept.Performed a visual inspection and found the part to be in good condition.The supplier found that fct failed due to a touch screen error.The supplier replaced u41 and thermal pad, then retested fct, and passed.See attached document for investigation received from the supplier.The failure analysis and testing dept.Installed exec.Processor board, into the cardiosave test fixture and tested the board to factory specifications per procedure number 0002-07-d016 revision e and the cardiosave service manual part number 0070-00-0639 revision r.The board passed testing.Retaining the board in the fat 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 be defined.

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: 17700797
• MDR Text Key: 322867682
• Report Number: 2249723-2023-03961
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.