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 Failure to Zero (1683); Failure to Shut Off (2939)

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

Event Date 02/09/2024

Event Type  malfunction  

Event Description

It was reported that during use on a patient , and post iab insertion ,the cardiosave intra-aortic balloon pump (iabp), the director call for assistance stating she couldn't see anything digital on the screen.Screenshots showed the pump was fine with an intact screen but the following alarms were present, transducer not zeroed, time in standby, and battery in use.The director was unwilling to do any sort of troubleshooting and blamed the pump for all issues.There was no patient harm or injury reported.

Manufacturer Narrative

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

Event Description

This report is being cancelled as it is a duplicate of mfg report number 2249723-2024-00730.

Manufacturer Narrative

This report is being cancelled as it is a duplicate of mfg report number 2249723-2024-00730 revert all sections to blank : b.Adverse event or product problem suspect medical device.Initial reporter.All manufacturers.Device manufacturers only.

• 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: 18740078
• MDR Text Key: 335767211
• Report Number: 2249723-2024-00720
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 72 KG