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 No Display/Image (1183)

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

Event Date 02/07/2024

Event Type  malfunction  

Event Description

It was reported that, the cs300 intra-aortic balloon pump (iabp) was having display issues.There was no harm reported.

Manufacturer Narrative

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

Event Description

It was reported that, the cs300 intra-aortic balloon pump (iabp) was having display issues.There was no patient involvement.

Manufacturer Narrative

Additional contact details: (b)(6).A getinge field service engineer (fse) replaced coiled cable (0012-00-1422) and screen still distorted.Replaced the display cable and screen still distorted.Replaced keypad controller and screen still distorted.Replaced the display and screen populated with no problems.Verified unit calibrated and passes all functional and safety tests per factory specifications.The reported problem was not duplicated or verified.Product passed all functional/safety testing.The defective components were received for further investigation.The failure analysis and testing dept.Received the following parts associated with this complaint: display cable, keypad controller, display and screen.Parts received with a reported failure of a display issue.The fat performed a visual inspection and found the parts to be in good condition.The fat installed coiled cable into cs300 test fixture and tested the part to factory specifications per the cs300 service manual part number 0070-00-0689 rev w.No issue confirmed.The fat installed display cable into cs300 test fixture and tested the part to factory specifications per the cs300 service manual part number 0070-00-0689 rev w.No issue confirmed.The fat installed keypad controller into cs300 test fixture and tested the part to factory specifications per the cs300 service manual part number 0070-00-0689 rev w.No issue confirmed.The fat installed display into cs300 test fixture and tested the part to factory specifications per the cs300 service manual part number 0070-00-0689 rev w.No issue confirmed.Retaining the parts in the failure analysis and testing department per procedure number 0002-07-d008 rev.Aq.The non-conformances with the returned components were not confirmed.However, the root cause or the most probable root cause is not confirmed.

• 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: 18713320
• MDR Text Key: 336082830
• Report Number: 2249723-2024-00665
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1