MAUDE Adverse Event Report: RESPIRONICS, INC. S PERFORMAX SU DOM WITH EE LEAK 2; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1052531
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Bradycardia (1751); Low Oxygen Saturation (2477)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer became aware of an event alleging that a performamax full face mask's elbow disconnected from the mask hub while in use with a v60 ventilator on a covid-19 patient.The was no allegation of malfunction against the ventilator.The user desaturated, became hypoxic and bradycardic, and medical intervention was required.The mask will not be returned for evaluation due to covid 19 contamination.Evaluation of same mask and lot number will be performed for investigation if available.A follow up final will be submitted when the investigation is completed.
Additional Manufacturer Narrative
The manufacturer became aware of an event alleging that a performamax full face mask's elbow disconnected from the mask hub while in use with a v60 ventilator on a covid-19 patient.There was no allegation of malfunction against the ventilator.The user desaturated, became hypoxic and bradycardic, and medical intervention was required.The mask will not be returned for evaluation due to covid-19 contamination.The product investigation laboratory purchased two performax mask assemblies, one small (lot # 88457011) and one long (lot # 93126293) performax mpu dom with ee leak 2 and se.The masks were received in january of 2023.Both masks were tested for elbow pull-out torque per prd # (b)(4), which requires the pull-out torque to be greater than 10 lbs.The large mask registered 65.34 lbs of pressure.A retest measured 57.33 lbs of pressure.The small mask registered 66.67 lbs of pressure.The retest measured 47.62 lbs of pressure.This mask has a history of complaints of the elbow coming out too easily, per customer.Due to the elbow being a force fit, the pull-out torque depends on how the elbow was placed in the swivel.Both masks were set up using a v-60 ventilator and the settings provided by the customer.Neither mask leaked nor was disconnected from the mannequin during the one hour each was tested for.Could not duplicate the customers' complaint. .

• Brand Name: S PERFORMAX SU DOM WITH EE LEAK 2
• 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 15206 ; 2673970028
• MDR Report Key: 13191447
• Report Number: 2518422-2022-00493
• Device Sequence Number: 4390273
• Product Code: BZD
• UDI-Device Identifier: 30606959004079
• UDI-Public: 30606959004079
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2023

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: 1052531
• Device Catalogue Number: 1052531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2021
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: V-60 VENTILATOR AVAPS 25-14, EPAP 12,100% O2
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Male