MAUDE Adverse Event Report: MINDRAY DS USA, INC. MINDRAY 17M PATIENT MONITOR AND MINDRAY MPM; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Device Problem No Display/Image (1183)

Patient Problem Insufficient Information (4580)

Event Date 01/13/2022

Event Type  malfunction  

Event Description

B/p cuff was placed on patient during an emergency situation.When the cuff started to inflate, the monitor went blank.Staff member reported that this has happened before with this same monitor.Fda safety report id# (b)(4).

Event Description

B/p cuff was placed on patient during an emergency situation.When the cuff started to inflate, the monitor went blank.Staff member reported that this has happened before with this same monitor.Fda safety report id# (b)(4).

• Brand Name: MINDRAY 17M PATIENT MONITOR AND MINDRAY MPM
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): MINDRAY DS USA, INC.; mahwah NJ 07430
• MDR Report Key: 13584336
• MDR Text Key: 286083906
• Report Number: MW5107623
• Device Sequence Number: 2
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/17/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1