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

Device Problems Thermal Decomposition of Device (1071); Mechanical Jam (2983); Temperature Problem (3022)

Patient Problem No Information (3190)

Event Date 01/29/2018

Event Type  malfunction  

Event Description

Iabp cardiosave hybrid.The machine would not print a strip.The door to the strip paper was hot to touch.When examined the paper appeared burned on one end and was black.Device under service agreement with manufacturer.Oem came in and inspected unit and performed necessary repairs.Manufacturer response for iap cardiosave hybrid, information not available (per site reporter) : repaired the machine.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 7713534
• MDR Text Key: 114842179
• Report Number: 7713534
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30295 DA
• Patient Weight: 67