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

Model Number 1061719

Device Problem Disconnection (1171)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/27/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 320862575
• Report Number: 2518422-2023-19365
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959007406
• UDI-Public: 00606959007406
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K101130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/10/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention