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

Model Number 0998-00-3023-53

Device Problems Electrical /Electronic Property Problem (1198); Appropriate Term/Code Not Available (3191)

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

Event Date 11/03/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate this unit and was able to reproduce "electrical test fails code 50" error.To correct the problem, the fse replaced the pcb motor controller.Subsequently, the fse completed a full calibration, functional and safety tests as per factory specifications.The unit passed all functional and safety tests per factory specifications.The iabp was returned to the customer and cleared for clinical use.Upon completion of our investigation, a supplemental report will be submitted.The full name of the event site was shortened due to field character limit; the full name is: (b)(6) medical center the name of the initial reporter has been abbreviated due to field character limit; the full name should read: (b)(6).

Event Description

It was reported that during a routine check, the cs300 intra-aortic balloon pump (iabp) was failing electric fault 50.There was no patient involvement, and no adverse event reported.

Event Description

N/a.

• Brand Name: CS300,ENGLISH,110V,DOMESTIC
• 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: 12844321
• MDR Text Key: 281021261
• Report Number: 2249723-2021-02702
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2022

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: Other
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/19/2021
• Supplement Dates Manufacturer Received: 06/16/2022
• Supplement Dates FDA Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1