MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS AMARA FULL-FACE MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems Airway Obstruction (1699); Low Oxygen Saturation (2477)

Event Date 01/23/2021

Event Type  Death  

Event Description

Philips respironics bipap mask (amara full-face mask) was taken out of the bag, and with the protective plastic covering still on the mask, the mask was strapped to the patient's face.Because of the non-porous, non-vented plastic covering, the mask was strapped to the patient's face.The patient immediately began desaturating (of course) and died of suffocation over the course of the next two minutes, in front of the ems workers and the family, none of whom knew what was happening at the time.They thought the patient was just simply coincidentally dying from her underlying natural disease.The family was videotaping this event (because the ems workers were reportedly providing them "instruction" on how to use this device).Only once the lady died did the son (not the ems worker) realize the mistake.The decedent was autopsied and the cause of death is "asphyxia due to airway obstruction." this is harris county institute of forensic sciences case number (b)(4).Our autopsy reports are available to the public so you can obtain a copy of this report.But clearly, there is an opportunity for philips to more clearly mark packaging material (which is attached to these masks) as packaging materials.Perhaps with big red letters "remove me before strapping on a patient" or something like that.This was an absolutely preventable death.The mask was retained as evidence in our office, and was subsequently transferred to the harris county sheriff office under their case number: (b)(4).Fda safety report id# (b)(4).

• Brand Name: PHILIPS AMARA FULL-FACE MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 13845917
• MDR Text Key: 287681568
• Report Number: MW5108354
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2022

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White