MAUDE Adverse Event Report: MINDRAY NORTH AMERICA - DATASCOPE CORP PASSPORT V MONITOR; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number 0998-00-6100

Device Problems Loss of Power (1475); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 03/16/2021

Event Type  malfunction  

Event Description

Blood pressure function on vitals monitor repeatedly failed to respond and a device shutdown/restart was required to continue to monitor patient vital signs.

• Brand Name: PASSPORT V MONITOR
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): MINDRAY NORTH AMERICA - DATASCOPE CORP; 800 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 12567889
• MDR Text Key: 274528020
• Report Number: 12567889
• Device Sequence Number: 1
• Product Code: MHX
• 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: 09/30/2021

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: No Information
• Device Model Number: 0998-00-6100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2021
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA