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

Catalog Number 0998-00-0800-53

Device Problems Calibration Problem (2890); Computer Operating System Problem (2898)

Patient Problem Death (1802)

Event Date 01/07/2017

Event Type  Death  

Manufacturer Narrative

On (b)(6) 2017 03:45 pm (gmt-5:00) added by (b)(6) (b)(4): the production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted.A company service representative was dispatched to evaluate the unit and was unable to reproduce the reported malfunction.The representative completed full calibration, functionality, and safety checks per factory specifications, and returned the unit to the customer for clinical use.***************************************************************************************** on (b)(6) 2017 10:45 am (gmt-5:00) added by (b)(6) (b)(4): the production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted.

Event Description

Initially, the customer reported that the unit generated ""fiber optic sensor calibration postponed" and "unable to update timing" while in use on a patient.Additional information was provided to us by the customer advising that the patient had expired.The customer is not attributing the patient's death to the device.

Event Description

Initially, the customer reported that the unit generated ""fiber optic sensor calibration postponed" and "unable to update timing" while in use on a patient.Additional information was provided to us by the customer advising that the patient had expired.The customer is not attributing the patient's death to the device.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 6301753
• MDR Text Key: 66546628
• Report Number: 2249723-2017-00004
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-0800-53
• Other Device ID Number: CH212819F5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 01/09/2017
• Date Device Manufactured: 06/23/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 52 YR