MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-53

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/18/2022

Event Type  malfunction  

Event Description

It was reported that, the cs300 intra-aortic balloon pump (iabp) unit ecg waveform is missing.

Manufacturer Narrative

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

Event Description

It was reported that during a routine check, the cs300 intra-aortic balloon pump (iabp) unit ecg waveform is missing.There is no patient involvement.

Manufacturer Narrative

Corrected sections: b5, b6, b7, d10, e3, h6(health clinical & impact).

Manufacturer Narrative

Getinge field service engineer (fse) customer complaint about ecg waveform missing in machine.Observed and found same.Also checked machine on system trainer but still ecg waveform is not there.Checked continuity of ecg connector to front end pcb cable but continuity is their and connector is ok.Front end pcb(d670-00-0668) was defective.Additional information was requested from the customer with regard to the repair and status of the iabp.Customer did repair.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
• 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: 15323837
• MDR Text Key: 305375722
• Report Number: 2249723-2022-02217
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K063525
• 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,Followup
• Report Date: 03/13/2024

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: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 09/08/2022; 02/28/2024
• Supplement Dates FDA Received: 03/01/2024; 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/06/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1