MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID INT TYP B PLUG"; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-53

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2022

Event Type  malfunction  

Event Description

It was reported that during periodic inspection, the cardiosave intra-aortic balloon pump (iabp) unit displayed system error #4 during clinical use.

Manufacturer Narrative

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

Manufacturer Narrative

It was reported that during clinical use the cardiosave intra-aortic balloon pump (iabp) had a system error #4 was displayed.A getinge field service engineer evaluated the unit and found power-up test fails code #4 was displayed.When fse checked the event log, event log fault codes 118 had occurred."sol wdt fail" - a critical error detected in the hardware watch dog circuit on the solenoid driver board was described in the service manual.Fse fixed the issue according to the fault code in the service manual.Returned to customer for clinical use.

• Brand Name: CARDIOSAVE HYBRID INT TYP 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: 15278231
• MDR Text Key: 305425062
• Report Number: 2249723-2022-02139
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

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: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1