MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PHILLIPS BEDSIDE MONITOR; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Device Problem No Audible Alarm (1019)

Patient Problems Apnea (1720); Hypoxia (1918); Diminished Pulse Pressure (2606)

Event Type  Injury  

Event Description

Bedside monitor did not alarm for apnea or desaturation, no audible alarms were turned off, all alarms within order parameters, this rn rounding found patient to be apneic and hypoxic without a pulse (pea on monitor) code initiated.

• Brand Name: PHILLIPS BEDSIDE MONITOR
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; cambridge MA 02141
• MDR Report Key: 15933155
• MDR Text Key: 305133949
• Report Number: MW5113680
• 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: 12/05/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White