MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC. PHILIPS INTELLIVUE MP5SC SPOT CHECK; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS

Model Number M8105AS

Device Problems Device Alarm System (1012); Product Quality Problem (1506); Low Readings (2460)

Patient Problem Fever (1858)

Event Date 08/17/2022

Event Type  malfunction  

Event Description

We have noted that the oral thermometer on the monitor was reading normal when the tympanic and oral disposable thermometers indicated temps were significantly higher for three different patients.The staff validated that the patients had not recently consumed cold beverages or ice chips prior to the oral measurements.Model # m8105as, serial #: (b)(4).Handheld tympanic or oral thermometer reading: 102.8 degrees f.Mp5sc reading: 98 degrees f, serial # (b)(4).Handheld tympanic or oral thermometer reading: 101.5 degrees f.Mp5sc reading 98.8 degrees f, serial # (b)(4).Handheld tympanic or oral thermometer reading: 101.2 degrees f.Mp5sc reading 98.4 degrees f.(b)(6) 2022, this issue was elevated to philips reps and (b)(6) has been actively working with their representatives.At this time, there is no known resolution to this issue.Currently (b)(6) staff are using handheld thermometers in the rooms with the known temperature result discrepancies.No patient harm has occurred with this issue at this time, but we continue to have concerns with the products lack of reliability in the clinical care of our patients.Additionally, the thermometers on the philips mp5sc monitors have been creating higher than desired thermometer inop alarms.(b)(6) has been working actively with philips reps since october 2021.Fda safety report id# (b)(4).

• Brand Name: PHILIPS INTELLIVUE MP5SC SPOT CHECK
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC.
• MDR Report Key: 15463264
• MDR Text Key: 300459460
• Report Number: MW5112211
• Device Sequence Number: 1
• 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: 09/20/2022
• 3 Devices were Involved in the Event: 1 2 3

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
• Device Model Number: M8105AS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander