MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-55

Device Problem Communication or Transmission Problem (2896)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2022

Event Type  malfunction  

Event Description

It was reported that , the cardiosave intra-aortic balloon pump (iabp) unit lacks internal communication.

Manufacturer Narrative

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

Event Description

It was reported that at start up, the cardiosave intra-aortic balloon pump (iabp) unit lacks internal communication.

Event Description

N/a.

Event Description

It was reported that at start up, the cardiosave intra-aortic balloon pump (iabp) unit lacks internal communication.No patient harm reported.

• Brand Name: CARDIOSAVE HYBRID W/ E/F PLUG
• 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: 16003873
• MDR Text Key: 308450090
• Report Number: 2249723-2022-03193
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/04/2023

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: Health Professional
• Device Model Number: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 12/13/2022; 03/24/2023; 04/04/2023
• Supplement Dates FDA Received: 12/22/2022; 03/27/2023; 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1