MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE G PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-52

Device Problem Circuit Failure (1089)

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

Event Date 12/29/2022

Event Type  malfunction  

Event Description

It was reported that during pre-use check, the cardiosave intra-aortic balloon pump (iabp) power management board faulty.There was no patient involvement.

Manufacturer Narrative

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

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate the issue.The fse found no charging light indicator on battery when the unit was off and plugged into ac to charge.The battery number selector however was lit up.The fse inspected the ac cord.The acdc power supply and continuity in hospital cart were all ok.The fse also observed that the fan was not running when the unit was off and plugged to ac to charge.The fse changed the fan but it was still not running.Then, the fse changed power management board and the fault cleared.The fse advised the user not to charge the batteries on this unit but instead to use the charging station.The unit was handed back to customer in good condition.

• Brand Name: CARDIOSAVE HYBRID, TYPE G 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: 16130645
• MDR Text Key: 308001054
• Report Number: 2249723-2023-00166
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108438
• UDI-Public: 10607567108438
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-52
• Device Catalogue Number: 0998-00-0800-52
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 04/09/2023
• Supplement Dates FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1