MAUDE Adverse Event Report: SIEMENS HEALTHCARE LIMITED SIEMENS SENSIS VIBE HEMODYNAMICS MONITORING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number SENSIS VIBE

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem Insufficient Information (4580)

Event Date 01/21/2021

Event Type  malfunction  

Event Description

During cath procedure, new siemens sensis vibe hemodynamics system locked up and had to be rebooted.This is not the first incident.Fda safety report id #: (b)(4).

• Brand Name: SIEMENS SENSIS VIBE HEMODYNAMICS MONITORING SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE LIMITED
• MDR Report Key: 11250778
• MDR Text Key: 229592002
• Report Number: MW5099078
• Device Sequence Number: 1
• Product Code: DQK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SENSIS VIBE
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 100