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 Problems Device Emits Odor (1425); Unexpected Shutdown (4019)

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

Event Date 10/11/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device(10) a getinge field service engineer (fse) was dispatched to evaluate this unit.Fse tested the unit and observed pump would power up without pressing the on/off switch.The cardiosave booted up with an "internal communication failure" alarm.Fse examined the fault log and observed fault code #139, power management communication failure.Then fse checked solenoid control board and observed burnt capacitor on circuit.Fse replaced power management board and solenoid circuit, which corrected the issue.The fse 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.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) shut down.There was a burning smell.Customer pulled battery out of unit and an alarm went off.Patient therapy was not delayed as unit was switched out with back up pump.There was no harm or injury to patient and no adverse event was reported.

Event Description

N/a.

Manufacturer Narrative

The following two faulty parts were returned to getinge's national repair center(nrc) for evaluation; pcb,power management and pcb,solenoid control.Inspection was completed per procedure with no visual damage observed to the power management board, but observed a burnt component c40 on the solenoid control board.The nrc installed the power management board into the cardiosave test fixture and tested the board to factory specifications and the cardiosave service manual.The nrc verified the failure of the cardiosave powering up without the on off switch being pressed.The board failed testing.The nrc could not install and test the solenoid control board due to the shorting of c40.The boards will be sent to the supplier for failure analysis per procedure.

• 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: 12739946
• MDR Text Key: 279695108
• Report Number: 2249723-2021-02538
• 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: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• 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