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 Failure to Power Up (1476)

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

Event Date 09/28/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device a getinge authorized dealer engineer tested the unit and confirmed that the pcba, video generator and pcba, upper display monitor were faulty.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) did not turn on after a software upgrade.Specifically, the getinge authorized dealer engineer confirmed the unit functioned properly, entered engineering mode to confirm all manifold test passed and inserted the usb to upgrade the altitude software upgrade.It was also reported that unit involved was taking out of service for further service and a cs100 iabp unit was provided to the customer as a back-up.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

A getinge service representative reported that the getinge distributor's field service engineer (fse) that evaluated the iabp as mentioned in the initial emdr, temporarily lent the control screen to the customer and released the iabp unit to the customer and cleared it for clinical service.A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h10.Getinge service representative reported that the iabp was not returned to the customer and not cleared for clinical use.They are waiting for the parts to arrive.A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

A getinge authorized dealer engineer advised that repairs are ongoing and pending receipt of replacement pcba, video generator and pcba, upper display monitor parts.The fse performed functional and safety checks to meet factory specifications.A supplemental report will be submitted upon completion of our investigation.The suspected defective pcba, video generator was returned to getinge national repair center (nrc) for failure investigation and was evaluated by a nrc senior service technician.Notably, the defective part was returned without the u43, microprocessor cooling fan, and the cooling fan was unscrewed from the board.Additionally, the defective part was returned to the nrc in a non-antic-static bag.The nrc installed the pcba, video generator into the cardiosave test fixture; however, the cardiosave text fixture would not properly boot up.The senior service technician reported that the cardiosave test fixture would not enter into service mode nor would allow reprogramming of the pcba, video generator board.As such, the failure of the board was confirmed.The defective pcba, video generator board is being retained at the nrc per procedure.A supplemental report will be submitted if additional information is provided.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Two suspected defective parts were evaluated with respect to this complaint.However, the evaluation for the suspected defective pcba, video generator was solely previously reported.The suspected defective pcba, upper display monitor was returned to getinge national repair center (nrc) for failure investigation and was evaluated by a nrc senior service technician.The board did not visually show any signs of a problem.The senior service technician installed the pcba, upper display monitor into the cardiosave test fixture, and confirmed that the cardiosave test fixture worked as intended per the cardiosave service manual.The senior service technician reported that the failure of the board was not confirmed.The defective pcba, upper display monitor is being retained at the nrc per procedure.A supplemental report will be submitted if additional information is provided.

Manufacturer Narrative

The dealer engineer returned the unit to the customer and a temporary control screen was lent to the customer.Repairs are ongoing and pending receipt of replacement pcba, video generator and pcba, upper display monitor parts.The fse performed functional and safety checks to meet factory specifications.A supplemental report will be submitted upon completion of our investigation.Fse said: on october 22, the dealer's engineer lent the spare machine to the customer for use.Currently waiting for the parts to arrive.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, e1 (site country), e3, g3, g6, h2, h4, h6 (type of investigation, investigation findings, component codes and investigation conclusions), h10, h11.Additional information: event site postal code: (b)(6).The maquet national repair center (nrc) inspected pcba, video generator per the cardiosave service manual part number 0070-00-0639 revision n.The board was returned to the nrc without the u43 microprocessor cooling fan, the cooling fan unscrewed from the board.The national repair center installed the pcba, video generator into the cardiosave test fixture.The cardiosave text fixture would not properly boot up.Both entering service mode and re-programming the pcba, video generator board could not be performed.The failure of the board was confirmed.Retaining the pcba, video generator board in the national repair center per procedure number 0002-07-d008 revision ae."the non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.The maquet national repair center (nrc) inspected the pcba, upper display monitor per the cardiosave service manual part number 0070-00-0639 revision n.The board visually showed no signs of problems.The national repair center installed the pcba, upper display monitor into the cardiosave test fixture serial number (b)(6).The cardiosave text fixture worked as it should per the cardiosave service manual part number 0070-00-0639 revision n.The failure of the board was not confirmed.Retaining the pcba, upper display monitor in the national repair center per procedure number 0002-07-d008 revision ae."the non-conformances with the returned components were not confirmed.However, the root cause or the most probable root cause is not confirmed.

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: 12685249
• MDR Text Key: 278128067
• Report Number: 2249723-2021-02443
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup,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: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 10/22/2021; 11/19/2021; 12/22/2021; 12/30/2021; 01/24/2022; 04/29/2024
• Supplement Dates FDA Received: 11/09/2021; 12/13/2021; 01/10/2022; 01/20/2022; 02/15/2022; 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.