MAUDE Adverse Event Report: PHILIPS PHILIPS MONITOR; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number MX800

Device Problems Therapeutic or Diagnostic Output Failure (3023); Unexpected Shutdown (4019)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/25/2020

Event Type  Injury  

Event Description

The customer reported that at the end of an ectopic pregnancy case on (b)(6) 2020 when the 31 year old female patient was being transferred to the bed, the upper phillips monitor failed and they could no longer ventilate the patient in bag or vent mode.The case began at 3:43 and was largely uneventful until the assumed time of the desaturation around 5:10 based on the sudden drop in et02.According to anesthesiologist blood oxygen saturation of the patient dropped to 32% according to a smaller side monitor.The intubated patient was switched to the device's auxilliary oxygen outlet with an ambu bag and recovered.The anesthesia machine was fully checked by a field service engineer, was found to be fully functional, and nothing was identified in the logs.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PHILIPS MONITOR
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS
• MDR Report Key: 17530036
• MDR Text Key: 321138152
• Report Number: MW5136956
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2020

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?: No
• Device Model Number: MX800
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Patient Age: 31 YR