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 Failure to Run on Battery (1466); Unexpected Shutdown (4019)

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

Event Date 11/30/2023

Event Type  malfunction  

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) switched to battery power  unexpectedly and ran the batteries down until it shut off.  patient was walking the hall on return they plugged in and noticed it wasn¿t charging.The   customer reported that the pump was swapped out and that there was no  harm to the patient.  therapy was delayed while the unit was  swapped out.  there was no patient harm but temporary intervention was needed.

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and the fse could not duplicate the issue (it was plugged in and fully charged when he arrived) but the fse did find that the power log indicated power/charging was swapping between a/c power and battery power frequently while it indicated the source to be the bulk supply.The batteries were at 14% & 15% from 14:57 to 16:10 while the power source remained on bulk sr.The fse replaced the power management board and completed a full system test (pm protocol).All tests passed to factory specifications.The fse left the unit powered on (ac power) all weekend and there were no additional power activities, the batteries remained charged.Returned to the customer and released for clinical use.The following investigation was performed by technician of the maquet failure analysis and testing dept.(fat) wayne, nj.The failure analysis and testing dept.Received pcb, power management, rohs with a reported unit failure of the unit switching to battery power unexpectedly and ran the batteries down until it shut off.The failure analysis and testing dept.Performed a visual inspection of pcb, power management, rohs and observed white residue on component l10.Based on pas experience, this residue is consistent with saline.Capa 14-ca-0097 has been initiated to address this issue.Due to the saline spill on the board and the risk it poses, this part cannot be investigated any further by the fat.

• 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: 18314249
• MDR Text Key: 330566771
• Report Number: 2249723-2023-05274
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 81 KG