MAUDE Adverse Event Report: RESPIRONICS, INC. AF531 EE LEAK1; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1061719
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	07/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Event or Problem Description
The manufacturer received information that a customer reported an event to the nmpa occurring on (b)(6) 2023.The customer stated that when a patient was using a v60 non-invasive ventilator, the connection of the af531 ee leak1 mask fell off, and the mask could not be used normally.This led to a decrease in blood oxygen and delayed treatment of the patient.The customer also reports that the clinical procedure/treatment was stopped and re-started, and the mask was replaced.No other clinical information or medical intervention was reported.(reference nmpa adverse event (b)(4).) the device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported information from a customer of an event occurring on july 27th, 2023.The customer stated that when a patient was using a v60 non-invasive ventilator, the connection of the af531 ee leak1 mask fell off, and the mask could not be used normally.This led to a decrease in blood oxygen and delayed treatment of the patient.The customer also reports that the clinical procedure/treatment was stopped and re-started, and the mask was replaced.No other clinical information or medical intervention was reported.(reference nmpa adverse event 1294426612023000217) the philips investigation lab received the m af531 ee leak1 4pt hdg, su (part # 1061719 lot # ap230208) with the complaint of "decrease in oxygen".The investigation lab could confirm the complaint of ¿decrease in oxygen¿.The philips investigation lab determined the hub¿s split washer was missing as the cause for the complaint.The investigation findings did not uncover any details that would change or modify the risk of the mask.The philips investigation lab did not observe any damage or defects to any of the returned mask assembly components but did notice the hub was not connected to the faceplate of the cushion.The click style hub¿s split washer was not returned.No imperfections which could result in the split washer being disconnected were observed.The philips investigation lab could not determine how/why the split washer was not in place.The returned mask assembly, supplemented with a known good split washer, was setup on a head mannequin and connected to a dreamstation device.The dreamstation device was turned on and ran for several minutes.No leaks were detected from the returned mask assembly when it was flexed.No leaks were detected from the elbow/exhalation feature.The returned mask assembly worked as designed.The philips investigation lab could confirm the complaint of ¿decrease in oxygen¿ and could determine the hub¿s split washer missing as the cause for the complaint.It was determined that based on the received visual evidence shown that no further corrective action is deemed appropriate for this mask assembly.No further investigation is needed.

• Brand Name: AF531 EE LEAK1
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17503903
• Report Number: 2518422-2023-19365
• Device Sequence Number: 12461654
• Product Code: BZD
• UDI-Device Identifier: 00606959007406
• UDI-Public: 00606959007406
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 1061719
• Device Catalogue Number: 1061719
• Device Lot Number: AP230208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown