MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems Device Emits Odor (1425); Failure to Power Up (1476)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge service territory manager (stm) was dispatched to investigate.The stm evaluated the iabp unit and observed the capacitor on the solenoid drive board was burned out and replaced the solenoid driver board.The motor control board was replaced after heat damage was observed.The smt also determined that the power management board had failed and replaced the part to correct the issue.Subsequently, the stm completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.(b)(6).

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) smells and will not boot up.It is unknown under which circumstances this event occurred or if a patient was involved; however, there was no adverse event reported.

Manufacturer Narrative

The suspected faulty power management board was returned from the supplier to getinge¿s national repair center (nrc).The supplier verified the failure of the cardiosave turning on automatically without pressing the on off switch.The supplier replaced q31,q32,q34,q35,q27,u14,u16 u20, q50 and cr54.The board failed testing on the cardiosave.The supplier stated that the board could not be repaired.The power management board will be retained in the nrc per procedure.No further investigation is required.

Event Description

It was reported that prior to use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a smell and would not boot up.There was no patient involved and no adverse event was reported.

Manufacturer Narrative

Updated fields: a1, a2, a3, a4, b4, b5, e1 (email address), g4, g7, h2, h6 (patient code), h10.The getinge service territory manager (stm) that performed the repairs, reported that the malfunction was reproducible prior to repairs.The suspected faulty solenoid drive board, motor control board and power management board were returned to getinge¿s national repair center (nrc) for evaluation.A senior repair technician inspected the solenoid drive board and observed visual damage to component c12 which had shorted and burned, and caused smoke damage to component c11.The national repair center could not test the board due to the shorting of c12.The senior repair technician retained the board in the national repair center per procedure.The senior repair technician inspected the motor control board and observed visual damage (smoke damage) to the solder side (left side) of the board.This damage was caused by the shorting of c12 on the board.The national repair center could not test the board due to the smoke damage to the board.The senior repair technician retained the board in the national repair center per procedure.The senior repair technician inspected the power management board and observed no visual damage to the board.The national repair center installed the board into the cardiosave test fixture and tested the board to factory specifications per procedure.The national repair center observed a failure of the board when the board was installed into the cardiosave.The cardiosave automatically turned on without pressing the on off switch.Also, the unit could not be turned off.The board failed testing.The board is to be sent to the supplier for failure analysis per procedure and upon the inspection of the board per procedure the installation is required.A supplemental report will be submitted upon completion of this investigation.

Event Description

It was reported that prior to use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a smell and would not boot up.There was no patient involved and no adverse event was reported.

• 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 07430
• MDR Report Key: 9013711
• MDR Text Key: 186014584
• Report Number: 2249723-2019-01459
• Device Sequence Number: 1
• Product Code: DSP
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1