MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH SYS98XT UPGRADED TO CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0479-53

Device Problem No Display/Image (1183)

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

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) , the cs300 intra-aortic balloon pump (iabp) display is broken.There was no patient involvement reported.

Manufacturer Narrative

Updated fields: b4, d1, d4(version or model #, catalog #), d9, g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h10.Additional contact details name: (b)(6).E-mail address: (b)(6).Phone number: (b)(6).Department: biomed.Occupation: biomedical engineer.A getinge field service engineer fse was dispatched to the site to evaluate the unit.He replaced main display screen, replaced display cable receiver, replaced label covers.Device passed all functional and safety tests according to factory specifications.Device was returned to customer.The failure analysis and testing dept.Received the following parts associated with this complaint: display, cable, mounting plate, these parts were received with the reported complaint of the display is broken.The failure analysis and testing dept.Performed a visual inspection and found the parts to be in good condition and did not observe any broken parts.The fat installed the parts into the into the cs300 test fixture serial number (b)(6) and tested the parts to factory specifications per the cs300 service manual part number 0070-00-0689 rev.W.The fat could not replicate the failure that the customer experienced.The parts passed testing.Retaining the parts in the fat per procedure number (b)(4).

Event Description

N/a.

• Brand Name: SYS98XT UPGRADED TO CS300
• 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: 18416517
• MDR Text Key: 331593325
• Report Number: 2249723-2023-05522
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 0998-00-0479-53
• Device Catalogue Number: 0998-00-0479-53
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2003
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.