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

Model Number 0998-00-0446-64

Device Problem Circuit Failure (1089)

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

Event Date 06/24/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), when checking the solenoid board on the cs300 intra-aortic balloon pump (iabp) it was found that there was a 2.3v instead on the minimum of 2.5v.There was no patient involvement.

Manufacturer Narrative

It was later informed by the fse that there was no more information since the customer has not accepted the quote and no interventions was planned.This complaint will be closed, if further information is received in regards to the repair of the unit, the complaint will be opened and updated accordingly.

• 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: 15028721
• MDR Text Key: 304521832
• Report Number: 2249723-2022-01717
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0446-64
• Device Catalogue Number: 0998-00-0446-64
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/15/2022
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 09/05/2023
• Date Device Manufactured: 08/24/1998
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1