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

Model Number 0998-00-0800-65

Device Problems Overheating of Device (1437); Unable to Obtain Readings (1516)

Patient Problem Ventricular Fibrillation (2130)

Event Date 11/10/2023

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that after three days use on patient, the cardiosave intra-aortic balloon pump (iabp) a nurse had noticed the unit had been in standby mode for an unknown period of time and an error message of " system over temperature" was displayed on the monitor.The physician decided to discontinue the iabp therapy since the patients condition had not improved and he was not expected to recover anymore, the patient had devolved ventricular fibrillation which was caused by anesthetic complications after an unknown surgery had been being treated by ecmo.The further treatment with the iabp therapy and pacemaker was required.The patient had expired later on the same day, according to the physician, the possible relationship between the patient's death and this issue and this iabp unit is low due to a poor outcome.This iabp was setting with maximum augmentation level and iab frequency of 1:1 by ecg trigger in auto operation mode.The trigger was lost occasionally.After iabp therapy ended, running test was performed with the internal trigger by a medical engineer of this facility until the morning of the following day; however the issue was unable to be replicated.

• 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: 18239211
• MDR Text Key: 329389860
• Report Number: 2249723-2023-05095
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-65
• Device Catalogue Number: 0998-00-0800-65
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Sex: Male