MAUDE Adverse Event Report: WELCH ALLYN, INC/ HILL-ROM, INC CONNEX SPOT VITAL SIGN EQUIPMENT; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number 75ME CONNEX SPOT VITAL MONITOR

Device Problems Fire (1245); Sparking (2595)

Patient Problem Insufficient Information (4580)

Event Date 09/09/2020

Event Type  malfunction  

Event Description

The device sparked and caught on fire.Fda safety report id # (b)(4).

• Brand Name: CONNEX SPOT VITAL SIGN EQUIPMENT
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN, INC/ HILL-ROM, INC
• MDR Report Key: 10561128
• MDR Text Key: 207770323
• Report Number: MW5096766
• Device Sequence Number: 1
• Product Code: MHX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/17/2020

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: 75ME CONNEX SPOT VITAL MONITOR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1