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

Device Problem Defective Component (2292)

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

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.This report is being submitted as the result of a retrospective review conducted in capa (b)(4).

Event Description

It was reported that a getinge field service engineer (fse) ordered two helium regulators for stock for cardiosave intra-aortic balloon pump (iabp), and upon receipt, it was clear from the packaging that one of the regulators was used.There was no malfunction of the iabp unit reported.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, d9, e1(site country), g3, g6, h2, h3, h4, h6(type of investigation, investigation findings, investigation conclusions), h10.It was reported that a getinge field service engineer (fse) ordered two helium regulators for stock for cardiosave intra-aortic balloon pump (iabp), and upon receipt, it was clear from the packaging that one of the regulators was used.There was no malfunction of the iabp unit reported.There was no patient involvement, and no adverse event reported.The defective components were received for further investigation.Please refer to the root cause evaluation field for details.In order to reproduce the failure, the suspect high pressure helium regulator was installed in the cardiosave test fixture.The following test was performed - leak test (sniffer) (seq.(b)(6)).Results : pass.The non-conformances with the returned components were not confirmed.However, the root cause or the most probable root cause is not confirmed.

Event Description

N/a.

• 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: 16258287
• MDR Text Key: 308539797
• Report Number: 2249723-2023-00644
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1