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

Model Number 0998-00-3023-55

Device Problems Break (1069); Connection Problem (2900)

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

Event Date 02/16/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the unit to be repaired.The fse dismantled the unit and refitted the pressure cable assembly, performed the cleaning process pursuant to getinge recommendation, replaced the front end board patient inputs, as well as inspected the unit and it's error logs.The fse then performed functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.(b)(6).

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) had a damaged pressure cable assembly.It is unknown the circumstances under which the event occurred.However, there was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The getinge field service engineer (fse) who evaluated the iabp and fixed the issue was the one who encountered the reported issue during a preventive maintenance (pm) that was been performed.The blood pressure cable assembly was also replaced in relation to the repairs mentioned in the initial emdr.The initial reporter named in block e1 is a getinge employee who has different contact details from that of the event site, and has the following contact information: (b)(4).A contact person at the customer or complainant site is (b)(6).

Event Description

It was reported that during a preventive maintenance (pm) performed by a getinge field service engineer (fse), it was found that the cs300 intra-aortic balloon pump (iabp) had a damaged pressure cable assembly.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the cs300 intra-aortic balloon pump (iabp) was found to have a damaged pressure cable assembly.There was no patient involvement, and no adverse event reported.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• MDR Report Key: 11464759
• MDR Text Key: 240391350
• Report Number: 2249723-2021-00500
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567112541
• UDI-Public: 10607567112541
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-3023-55
• Device Catalogue Number: 0998-00-3023-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/29/2021
• Patient Sequence Number: 1