MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100,ENGLISH,NON-UTS,INTL; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-55

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a routine check, the cs100 intra-aortic balloon pump (iabp) unit's electrical test fails code # 50.There was no patient involved.

Manufacturer Narrative

Additional fields: e1(event site state:25, event site postal code: (b)(6).) it was reported that cs100 intra-aortic balloon pump (iabp) electrical test fails code 50#.Getinge field service engineer (fse) found checked and found same problem , and problem is iabp showing error - electrical test fail code # 50.After inspection found pcb motor control ( part no - d671-00-0004) defective.So need to be replaced.Despite gfes (good faith efforts), no response has been received regarding any repair or the status of the iabp.If any pertinent information is received in the future, the complaint will be reopened and updated accordingly.No patient involvement.

• Brand Name: CS100,ENGLISH,NON-UTS,INTL
• 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: 18384802
• MDR Text Key: 331242582
• Report Number: 2249723-2023-05486
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107295
• UDI-Public: 10607567107295
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/27/2024

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: 0998-00-3013-55
• Device Catalogue Number: 0998-00-3013-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 05/27/2024
• Supplement Dates FDA Received: 05/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1