MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVEHYBRID INT TYPE E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-55

Device Problem Failure to Charge (1085)

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

Event Date 05/21/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse confirmed the issue.The fse determined the customer did not connect it to the mains long enough while the iabp was not in use.The batteries were replaced.A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that during a routine check, the batteries of the cardiosave intra-aortic balloon pump (iabp) would not charge.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The getinge field service engineer (fse) that evaluated the iabp as mentioned in the initial emdr, reported that once the batteries were replaced, the iabp would not charge them.After further inspection, the fse found the power management board defective.The fse replaced it and then everything was working fine.All functional and safety checks to meet factory specifications was performed.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.The defective power management board was requested to be returned for failure investigation.A supplemental report will be submitted when this information is provided to us.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h10.The pcb,power management,rohs was returned to the manufacturer for further evaluation.A senior repair technician of the national repair center (nrc) completed the inspection per procedure with damage observed to component q27 which is shorted.The technician was not able to test the board due to the shorting of q27.Past experience has proven that when q27 shorts, the batteries will not charge.The power management board was sent to the supplier for failure analysis per procedure.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h10.The supplier returned the power management board to the national repair center (nrc).The supplier verified the failure of the batteries not charging and replaced q27 and q50.The board is to be retained in the nrc per procedure.A supplemental report will be submitted upon completion of our investigation.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g2, g3, g6, g7, h2, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected fields: d10, h6 (component codes).

• Brand Name: CARDIOSAVEHYBRID INT TYPE E/F 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: 12009305
• MDR Text Key: 256507036
• Report Number: 2249723-2021-01265
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.; UNKNOWN.; UNKNOWN.