MAUDE Adverse Event Report: PHILIPS HEALTHCARE M3001A MMS MODULE; MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARM)

Model Number M3001A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Code Available (3191)

Event Date 07/23/2019

Event Type  malfunction  

Event Description

Overview: patient received unnecessary medical treatment in response to incorrect spo2 levels from bedside patient monitor.Details according to internal patient safety report.Patient was admitted for status asthmaticus who was oxygenating well with good spo2.At approximately 1500 the patient was noted to be hypoxic with oxygen saturations in the mid 80s.The patient was placed on 100% fio2 on the vent without improvement and therefore the patient was bagged.This did not improve the patient's oxygen saturations, therefore us was performed which showed no signs of a pneumothorax or pulmonary edema.Due to hypoxia, the patient was given a dose of rocuronium with minimal improvement of his oxygenation saturations.Due to this worsening hypoxia, we were considering proning the patient and calling ct surgery for possible ecmo placement.The patient was then noted to be at 100% without any changes to the vent and his spo2 was 226 which shows that the patient was oxygenating well throughout the events.Additional notes: clinical staff attempted multiple troubleshooting techniques to rul out misreading due to sensor placement, bad cable, etc.On-going issue with multiple mms modules.This particular incident was reported internally to the patient safety reporting site.Manufacturer is also aware through account manager and case number for the issue has been generated.Manufacturer fse currently troubleshooting and installing potential remediation.Fda safety report id # (b)(4).

• Brand Name: M3001A MMS MODULE
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARM)
• Manufacturer (Section D): PHILIPS HEALTHCARE
• MDR Report Key: 8861025
• MDR Text Key: 153837596
• Report Number: MW5088734
• Device Sequence Number: 0
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3001A
• Device Catalogue Number: 862442
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Weight: 77