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); Failure to Power Up (1476)

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

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

The fse returned to the customer's site at a later date to perform the repairs of the iabp unit.The fse noted that the iabp unit had lost communication from the power butted to the iabp unit.The fse replaced the executive processor board, front end board, and power management board to resolve the issue.The fse then completed pm service including 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 during preventative maintenance (pm) performed by a getinge field service engineer (fse), the cariosave intra-aortic balloon pump (iabp) lost communication to power up.Once the iabp unit was able to be powered-up, the fse smelled smoke from a burnt board.The iabp unit then generated an electrical alarm.There was no patient involvement, and no adverse event was reported.

Manufacturer Narrative

The suspected faulty executive processor board, power management board and front end board were returned to getinge's national repair center (nrc) for failure investigation.A getinge senior technician (st) inspected the executive processor board and observed capacitor (c1) was severely burned.Using an ohmmeter, measuring across the burned capacitor (c1), the capacitor measured 8 ohms in both direction.The capacitor had failed and shorted and burned.The executive processor board was retained in the nrc per procedure.The st then inspected and then installed the power management board into the cardiosave test fixture.The st observed that the iabp unit was unable to power up.The power management board will be sent to the supplier per procedure.Lastly, the st inspected the front end board and observed that it was marked with black soot that apparently came from when the nearby executive processor board capacitor (c1) burned.The front end board was not powered up as it is no longer usable due to its blackened damaged condition.The front end board will not be used again and will be retained in the nrc per procedure.A supplemental report will be submitted when additional information is received.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g3, g6, g7, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: g1(contact person).The national repair center received the exch pcb, power management,rohs from the supplier.The supplier verified the failure and found components q31,q33, and q35 defective.Retaining the board in the nrc 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12529604
• MDR Text Key: 280698976
• Report Number: 2249723-2021-02176
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• 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
• Date Returned to Manufacturer: 12/01/2021
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1