MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, PORTUGUESE,NON-UTS,DOM; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-68

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device the fse located the cause of the reported malfunction to be in the mains input plug, as well as the power supply showing electrical damage.The fse resolved the issue by replacing the power supply assembly.The fse completed pm with calibration, functional and safety checks to meet factory specifications.The equipment was confirmed to be operational.A supplemental report will be submitted upon completion of our investigation.(b)(6).The full name of the event site was shortened due to field character limit; the full name is (b)(6).

Event Description

It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the cs100 intra- aortic balloon pump (iabp) unit failed electrical safety checks.Specifically, an electrical insulation test failure was found.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields - b4, e1(site country, event site postal code - (b)(6)), g3, g6, g7, h2, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.E1 - event site address line 2 is "blank" initially it was submitted incorrectly.Corrected fields - d4 (version or model, catalog, unique identifier (udi)).Additional point of contact - (b)(6).

Event Description

N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, PORTUGUESE,NON-UTS,DOM
• 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: 14028440
• MDR Text Key: 289773229
• Report Number: 2249723-2022-00746
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

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: Other
• Device Model Number: 0998-00-3013-68
• Device Catalogue Number: 0998-00-3013-68
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 04/06/2022
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2004
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1