MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-55

Device Problem Failure to Power Up (1476)

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

Event Date 10/27/2023

Event Type  malfunction  

Event Description

It was reported that during a routine check when the power button is pressed the cardiosave intra-aortic balloon pump (iabp) does not turn on.There was no patient involvement reported.

Manufacturer Narrative

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

Manufacturer Narrative

Updated fields: h6 (type of investigation, investigation findings, investigation conclusion).Additional information: e1(event site postal code-(b)(6)).It was reported that the cardiosave intra-aortic balloon pump (iabp) unit does not turn on and does not charge the batteries.A getinge field service engineer (fse) stated the presence of saline solution found which had penetrated the machine probably from the front fan compartment, dripping from a bag.The power management board needs to be replaced.Following acceptance of the quote by the customer, replaced power management board, the repair is carried out.No patient involvement.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID W/ 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: 18085779
• MDR Text Key: 327549170
• Report Number: 2249723-2023-04767
• 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,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.