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

Model Number 0998-00-0800-55

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 03/07/2022

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the unit and found the x4-external helium tank prs.(psig) is broken which confirmed the reported issue.The fse has not completed the repair, thus a supplemental report will be submitted upon receipt of additional information.The full name of the event site is (b)(6).The full name of the initial reporter is (b)(6).

Event Description

It was reported that during a routine check, the cardiosave intra-aortic balloon pump (iabp) unit has the wrong helium indicator.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate the issue.The fse stated that an earlier inspection revealed that the helium gas status on the display was incorrect.The fse noticed that the hi press 3500 psig had a problem and was causing the helium reading to come out incorrectly, so, in order to fix the issue, the fse replaced the hi press 3500 psig (0682-00-0092-01).After the replacement, the fse found the helium indicator to be normal.The machine was then cleared for use.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID INT TYPE E/F 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: 13956129
• MDR Text Key: 290165525
• Report Number: 2249723-2022-00697
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.