MAUDE Adverse Event Report: PHILIPS PHILIPS MONITOR; CARDIAC MONITOR

Model Number M1092A

Device Problems Sparking (2595); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2015

Event Type  malfunction  

Event Description

Cardiac monitor in patient's room made popping noise, patient saw sparks from behind the monitor.Monitor unplugged.No patient injury.

• Brand Name: PHILIPS MONITOR
• Type of Device: CARDIAC MONITOR
• Manufacturer (Section D): PHILIPS; boston MA
• MDR Report Key: 5513407
• MDR Text Key: 40845590
• Report Number: MW5060956
• Device Sequence Number: 1
• Product Code: DRT
• 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: 03/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M1092A
• Other Device ID Number: IDH22823
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR