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 Date 01/26/2022

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device|10: a getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.To fix the issue the fse replaced the failed power management board and the batteries, which were completely depleted and unusable, then performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that during use on a patient the batteries on the cardiosave intra-aortic balloon pump (iabp) were not charging.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.To fix the issue the fse replaced the failed power management board and the batteries, which were completely depleted and unusable, then performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that during use on a patient the batteries on the cardiosave intra-aortic balloon pump (iabp) were not charging.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

The investigation of the pcb,power management, rohs was performed at getinge's national repair center(nrc) per procedure and to the ipc-a-610 standard with no visual damage observed.The nrc installed the board into the cardiosave test fixture and tested the board to factory specifications per procedure and the cardiosave service manual.The nrc first proceeded to charge the batteries in the cardiosave console.The nrc observed that the batteries charged in the cardiosave console with no problem found.The nrc then installed the console into the cardiosave cart.Two batteries were installed one in slot 1 and one in slot 2.The nrc observed that the batteries would not charge in either slot.The board failed testing.The nrc will send the board to the supplier for failure analysis per procedure.

Manufacturer Narrative

Updated fields: b4, e1 (site country), g3, g6, h2, h4, h6 (type of investigation, investigation findings and investigation conclusions), h10.Additional contact details: (b)(4).The maquet national repair center (nrc) received the pcb,power management from the supplier.The supplier verified the failure of the batteries not charging and found component q27 was defective.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.Retaining the board in the nrc per procedure number (b)(4).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: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 13571651
• MDR Text Key: 286082903
• Report Number: 2249723-2022-00345
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: INTRA-AORTIC BALLOON CATHETER