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 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp unit and noticed the helium cover was not attached properly and the release latch was stuck not allowing rescue unit secure into the cart.The fse also verified the batteries were not charging, and the led indicator was not lit when the unit was plugged in.The fse troubleshot the issue and found the power management board to be bad, and replaced the power management board.The iabp unit was now charging the batteries.The fse fixed the helium cover and latch and now the unit is operating correctly.All calibration, functional and safety checks to meet factory specifications was performed.Unit passed all calibration, 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 the cart of he cardiosave intra-aortic balloon pump (iabp) was damaged and the batteries would not charge when the iabp was plugged in.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: e (occupation, initial reporter, health professional?.

Manufacturer Narrative

The suspected faulty power management board (pmb) was returned to getinge's national repair center (nrc) for failure investigation.A getinge technical associate inspected the pmb per procedure and no visual damage was observed.The nrc installed the pmb into the cardiosave test fixture and tested the pmb to factory specification per procedure.The nrc was unable to verify the reported issue and was able to charge the batteries to factory specifications with no trouble found.The pmb passed testing and was sent to the supplier per procedure.A supplemental report will be submitted upon completion of the supplier's evaluation.

Event Description

N/a.

Manufacturer Narrative

The power management board (pmb) was received back at getinge's national repair center(nrc) from the supplier.The supplier stated no abnormalities found.The board passed testing.Inspection of the board was completed per procedure and to the ipc-a-610 standard and 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 board passed testing.The nrc will be retaining the board per procedure.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g3, g6, g7, h2, h6(investigation type), h10, h11 corrected fields: g1(contact person), h4.

• 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: 11787459
• MDR Text Key: 249452963
• Report Number: 2249723-2021-00961
• 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: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1