MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC. PHILIPS CARDIAC MONITOR; MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)

Device Problem Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Philips cardiac monitor keeps turning off / on its own every few minutes, error reads fms unplugged, monitor reboots on own.Fda safety report id# (b)(4).

• Brand Name: PHILIPS CARDIAC MONITOR
• Type of Device: MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC.
• MDR Report Key: 13306959
• MDR Text Key: 284213644
• Report Number: MW5106810
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/14/2022

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: 01/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Male