MAUDE Adverse Event Report: RESPIRONICS, INC. XXS PERFORMAX SE; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	1083086
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Loss of consciousness (2418)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that a baby required "reanimation" when the elbow of a performax pediatric mask became disconnected from the faceplate hub while using non-invasive ventilation.There was no clear information regarding the status of the baby, or the intervention required, and no patient information was provided.The manufacturer's investigation is on-going.Upon completion of the manufacturer's investigation, a follow up report will be submitted.
Additional Manufacturer Narrative
The manufacturer received information initially that a baby required "reanimation" when the elbow of a performax pediatric mask became disconnected from the faceplate hub while using non-invasive ventilation.It was clarified at a later date that the mask was in use for one day on a female infant, 80 days old, 3.2 kg weight who required non-invasive ventilation due to a consolidation in the right upper lobe of the lungs with increased respiratory distress.Cardiopulmonary resuscitation was required at the time of the event.The infant is reportedly stable now.The manufacturer received the mask for investigation.There were no operational defects noted.There is no adhesive used in the manufacture of this mask to keep the elbow in place at all times, however, the elbow should be locked into the hub of the faceplate to ensure connection.The certificate of conformance received from the factory indicates the mask was manufactured to specifications.The performax pediatric se total face mask is intended to provide a patient interface for application of noninvasive ventilation.The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer cpap or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea.The mask is for single use in the hospital/institutional environment only.The mask is to be used on patients 1 year or older (>7 kg) who are appropriate candidates for noninvasive ventilation.Users are warned that this mask is not suitable for life support ventilation.As the patient was only 80 days old, and 3.2 kg in weight, this mask was not recommended for use.The manufacturer is unable to determine the root cause of the event.The mask functioned as designed and passed all testing.Based on the information available, the manufacturer concludes no further action is required.

• Brand Name: XXS PERFORMAX SE
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 10622193
• Report Number: 2518422-2020-02346
• Device Sequence Number: 14294871
• Product Code: CBK
• UDI-Device Identifier: 00606959008069
• UDI-Public: 00606959008069
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: KK120639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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: 1083086
• Device Catalogue Number: 1083086
• Device Lot Number: 200223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 10/20/2020
• 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: Required Intervention
• Patient Age: 80 DA
• Patient Weight: 3