MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR AUTO P-FLEX; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	568P
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Conjunctivitis (1784); Headache (1880); Choking (2464); Unspecified Respiratory Problem (4464); Unspecified Eye / Vision Problem (4471); Skin Disorders (4543)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was contacted in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The patient has alleged patient skin problems, headaches, coughing, choking at night, conjunctivitis, blepharitis, headaches, cough, sensation of suffocation and two micro-nodules.There was report of serious patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.

• Brand Name: REMSTAR AUTO P-FLEX
• 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: 18902303
• Report Number: 2518422-2024-13834
• Device Sequence Number: 21116033
• Product Code: BZD
• UDI-Device Identifier: 00606959031159
• UDI-Public: 00606959031159
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: Lay User/Patient
• Device Model Number: 568P
• Device Catalogue Number: 568P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1973-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown