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 Charge (1085)

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

Event Type  malfunction  

Event Description

It was reported that during routine check, the cardiosave intra-aortic balloon pump (iabp) would not chare battery #2.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

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.

Manufacturer Narrative

Updated fields: b4.G4.G7.H2, h6 (type of investigation), (component codes), h10, h11 corrected fields: d10, e1 (event site name, event site address, event site address line 2, event site city, event site state, event site postal code, event site telephone) testing of actual/suspected device: (10/3233) a getinge field service engineer (fse) was dispatched to evaluate this unit and when arrived to the site, the fse was able to confirm that the device was not charging either batteries.The fse replaced the batteries, to resolve the issue, but during testing, the device continued failing to charge the batteries.After further troubleshooting, the fse was able to find that the that power management board was faulty.The fse replaced the power management board and the unit began charging the batteries.The unit was calibrated and it passed all functional and safety tests per factory specifications.The iabp was released to the customer and cleared for clinical service.It is expected that the suspected faulty power management board will be returned to getinge's national repair center for failure analysis; a supplemental report will be submitted upon completion of failure analysis.

Event Description

N/a.

Event Description

It was reported that during routine check, the cardiosave intra-aortic balloon pump (iabp) would not charge battery #2.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The power management board was received at getinge's national repair center (nrc) for failure investigation.A supplemental report will be summitted when additional information is provided.

Event Description

N/a.

Manufacturer Narrative

Updated fields - (site country).Corrected fields - (,event site telephone).A getinge field service engineer (fse) onsite confirmed device was not charging either batteries.So, fse replaced batteries,device failed to charge batteries.After further troubleshooting it was found that power management board was faulty.After replacing power management board device began charging batteries.Unit calibrated and passed all functional and safety tests per factory specifications.Returned to customer and cleared for clinical use.The defective components were received for further investigation.Please refer to the root cause evaluation field for details.Inspection of the pcb,power management,rohs part number serial number was completed per procedure number 0002-07-d014 revision g and to the ipc-a-610 standard revision h with visual damage observed to component q27 shorted (burned).Due to the shorting of q27, the board cannot be installed into the cardiosave to be tested.Past experience has proven that when q27 shorts, the batteries will not charge.Sending the board to the supplier for failure analysis per procedure number 0002-07-d008 revision ag.Cf (b)(6) 2023- the new supplier escatec, will no longer accept swemco boards back for failure analysis.Further failure analysis is not possible.The board will be scrapped per procedure number0002-07-d008 rev.Al.The non-conformances with the returned components were confirmed.However, the 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: 12846876
• MDR Text Key: 283392903
• Report Number: 2249723-2021-02661
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/19/2024

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/19/2021
• Supplement Dates Manufacturer Received: 11/16/2021; 03/30/2022; Not provided
• Supplement Dates FDA Received: 12/10/2021; 04/27/2022; 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1