MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-53

Device Problems Device Displays Incorrect Message (2591); Appropriate Term/Code Not Available (3191)

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

Event Date 11/04/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had a monitor that was unable to be removed from service mode.There was no patient involvement, and no adverse event was rep.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate this unit.Upon initial check of unit, and all operational functions of the iabp unit, the fse noted that the unit functioned normally.The fse was able to enter the service mode, but that was as far into the menu functions than the fse could access.The menu would lock up, freeze, and become unresponsive.The fse was unable to open any and all of the menu functions available in the service mode.The unit was powered down.The fse powered the unit back up into normal operational mode, all functions worked normally.The fse replaced the video generator board which did not correct the issue.Subsequently, the fse replaced the front end pcb which also did not repair the unit.The fse then replaced the executive processor board which was observed to have repaired the unit.The fse reinstalled the customers' original video generator board and front end board then uploaded the latest software version and performed calibration and preventative maintenance (pm) procedures.The unit passed all calibration, functional and safety tests performed.The unit was returned to customer and cleared for clinical use.A supplemental report will be submitted upon completion of our investigation.The full name of the event site in block e1 was shortened due to field character limit; the full name is (b)(6).

• Brand Name: CARDIOSAVE HYBRID, TYPE B PLUG
• 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: 12858206
• MDR Text Key: 285323615
• Report Number: 2249723-2021-02717
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1