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 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device (10/213): a getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and observed no fan operation, as well as observed the battery charge for 30 seconds before it stopped.The fse checked the batteries, but did not observe a failure.The fse isolated the failure to the power management board, specifically observed burned component on the power management circuit.The fse resolved the reported issue by replacing the power management board and confirmed that the battery charged to specifications.Unit passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.A supplemental report will be submitted if additional information is provided.The full name of the initial reporter that is abbreviated is (b)(6).

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) battery would not charge.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

Manufacturer Narrative

The suspected faulty power management board was sent to getinge's national repair center (nrc) for evaluation.A senior repair technician inspected the power management board with visual damage observed to q27.Upon measuring the source, gate and drain with an ohm meter, it was observed that q27 is shorted.Due to the shorting of q27, the national repair center was not able to install the board into the cardiosave test fixture and test the board.However, experience has proven that when q27 shorts , the unit would turn on, but the batteries will not charge.The power management board had failed for the shorting of q27.The power management board is being sent to the supplier per procedure.A supplemental report will be submitted when additional information is provided.

Event Description

N/a.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and observed no fan operation, as well as observed the battery charge for 30 seconds before it stopped.The fse checked the batteries, but did not observe a failure.The fse isolated the failure to the power management board, specifically observed burned component on the power management circuit.The fse resolved the reported issue by replacing the power management board and confirmed that the battery charged to specifications.Unit passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.The suspected faulty power management board was sent to getinge's national repair center (nrc) for evaluation.A senior repair technician inspected the power management board with visual damage observed to q27.Upon measuring the source, gate and drain with an ohm meter, it was observed that q27 is shorted.Due to the shorting of q27, the national repair center was not able to install the board into the cardiosave test fixture and test the board.However, experience has proven that when q27 shorts , the unit would turn on, but the batteries will not charge.The power management board had failed for the shorting of q27.The power management board is being sent to the supplier per procedure.The national repair center received the exch pcb, power management rohs from the supplier.The supplier verified the failure of the batteries not being charged and found that components q27, cr54 and q50 were defective.Retaining the board in the nrc per procedure.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.

• 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: 12094534
• MDR Text Key: 263554282
• Report Number: 2249723-2021-01398
• 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: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• 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
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose