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 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the cardiosave iabp trainer.The trainer was missing the a line, so the trainer (0998-00-0803) was replaced.Since this is an accessory, no measurements could be recorded 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 intra-aortic balloon pump (iabp) does not display balloon pumping in "a' line during operation.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: 16224404
• MDR Text Key: 308543443
• Report Number: 2249723-2023-00296
• 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: 01/11/2023

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: 07/31/2020
• Initial Date FDA Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1