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

Device Problems Computer Operating System Problem (2898); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 01/25/2021

Event Type  malfunction  

Event Description

During cardiac catherization the seimans sensis vibe system freezes up and has to be rebooted by the staff.Fda safety report id #: (b)(4).

• Brand Name: SEIMANS SENSIS VIBE HEMODYNAMIC MONITORING SYSTEM/SENSIS VIBE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE LIMITED
• MDR Report Key: 11250755
• MDR Text Key: 229591979
• Report Number: MW5099077
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/26/2021

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2021
• 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: 72 YR
• Patient Weight: 88