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

Device Problems Therapeutic or Diagnostic Output Failure (3023); Unexpected Shutdown (4019)

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

Event Date 10/13/2022

Event Type  malfunction  

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit had an error code 4561.There was no patient involvement.

Manufacturer Narrative

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

Manufacturer Narrative

Updated field: b4, d9, e1-(site country, site email), g3, g6, h2, h3, h4, h6(medical device ¿ problem code, type of investigation, investigation findings, investigation conclusions),h10.It was reported that the cs300 intra-aortic balloon pump (iabp) unit had error code 4561.Customer complained that during patient transport the unit shut down.No patient death or injury reported.A getinge field service engineer (fse) evaluated the unit and found the k3/k5 assy was loose and touched the solenoid driver board causing it to short.There was no damage to any parts.Fse secured the assy and also performed a pm during this call.Unit passed all functional and safety tests per factory specifications.Returned unit to the customer and cleared for clinical use.

• 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: 15640123
• MDR Text Key: 304087250
• Report Number: 2249723-2022-02723
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2001
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1