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

Model Number 0998-00-0803

Device Problem Communication or Transmission Problem (2896)

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

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) was assigned to investigate the unit for the reported issue and the stm stated that this trainer was tested on multiple units and found that there is nothing wrong with it.Since the trainer belongs to a clinical specialist and it is a getinge owned tool that is used for simulation on a cardiosave iabp, the stm returned the trainer to the owner.No service was required.This report is being submitted as the result of a retrospective review conducted in capa (b)(4).

Event Description

It was reported that during training, the cardiosave accessory trainer simulator was showing error.There was no patient involvement reported.

• Brand Name: CARDIOSAVE TRAINER
• 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: 16272439
• MDR Text Key: 308780918
• Report Number: 2249723-2023-00611
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/13/2023

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: 0998-00-0803
• Device Catalogue Number: 0998-00-0803
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1