MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH PRODUCT NOT IN LIST - IABP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number PRODUCT NOT IN LIST - IABP

Device Problem Failure to Sense (1559)

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

Event Date 06/05/2021

Event Type  malfunction  

Manufacturer Narrative

Device not accessible for testing (4117): after further investigation, the pump was not the problem or did not have any malfunction.¿the cable was malfunctioning.The replacement cable worked well.These cables come from the hospital's disposable transducer companies, not from getinge.This is not a pump problem, and the cable is again, not our product".A supplemental report will be submitted upon completion of our investigation.The full event site name is (b)(6) medical center.

Event Description

It was reported during use on a patient the arterial line image disappeared from the iabp console.No patient harm, serious injury or adverse event was reported.

• Brand Name: PRODUCT NOT IN LIST - IABP
• 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: 12088693
• MDR Text Key: 259216734
• Report Number: 2249723-2021-01383
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRODUCT NOT IN LIST - IABP
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose