MAUDE Adverse Event Report: RESPIRONICS, INC. AF541 EE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	AF541
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Death (1802)
Date of Event	09/01/2020
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received a voluntary medwatch ((b)(4)) in which it is alleged a patient death occurred.A mask was reportedly in use on the patient for 3 days at a facility, and a pressure ulcer developed on the bridge of the patient's nose.The pressure ulcer was treated with bacitracin ointment.The manufacturer contacted the reporting facility for additional information.There was no date of death provided, no cause of death, and no rationale as to how the use of the mask and subsequent development of a pressure ulcer may have caused or contributed to the patient death.No product was returned for investigation.This mask is intended to provide an interface for application of cpap or bi-level therapy to patients.The mask is for single use in the hospital/institutional environment only.The mask is to be used on patients (>40lbs/20kg) for whom cpap or bi-level therapy has been prescribed.This mask should not be used on patients who need life support ventilation, who are taking a prescription drug that may cause vomiting, or on patients that are uncooperative, unresponsive, or unable to remove the mask by themselves.Labeling warns the caregiver to "monitor or intervene if the patient experiences skin redness, irritation, discomfort, blurred vision, or drying of the eyes.Do not overtighten the headgear straps.Watch for signs of overtightening, such as excessive redness, sores or bulging skin around the edges of the mask.Loosen the headgear straps to alleviate symptoms." although a death occurred, the manufacturer is unable to confirm the mask caused or contributed to the event.Based on the information available, the manufacturer concludes no further action is necessary.

• Brand Name: AF541 EE
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville, pa
• MDR Report Key: 10494972
• Report Number: 2518422-2020-02086
• Device Sequence Number: 3583790
• Product Code: BZD
• UDI-Device Identifier: 00606959024434
• UDI-Public: 00606959024434
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AF541
• Device Catalogue Number: AF541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 52 YR