MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE I (AU); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-31

Device Problems Electrical /Electronic Property Problem (1198); Retraction Problem (1536)

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

Event Date 03/24/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the cardiosave intra-aortic balloon pump has a faulty power cord retractor.There was no patient harm reported.

Event Description

It was reported that during routine check the cardiosave intra-aortic balloon pump has a faulty power cord retractor.There was no patient involvement.

Manufacturer Narrative

Additional fields: e1 (event site state: nsw, event site postal code: (b)(6)) it was reported that the cardiosave intra-aortic balloon pump (iabp) nsph rp cs faulty power cord retractor, there was no patient involvement and no patient harm reported.A getinge field service engineer fse was dispatched to the site to evaluate the unit.Replaced power cord due to faulty mechanism.Electrical safety test has passed.The defective components were received for further investigation.After that, fat evaluation able to verify problem.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID TYPE I (AU)
• 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: 16673610
• MDR Text Key: 312633157
• Report Number: 2249723-2023-01752
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567109053
• UDI-Public: 10607567109053
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 03/18/2024

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: Health Professional
• Device Model Number: 0998-00-0800-31
• Device Catalogue Number: 0998-00-0800-31
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 04/18/2023; 03/13/2024
• Supplement Dates FDA Received: 05/01/2023; 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1