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

Model Number 568P

Device Problem Degraded (1153)

Patient Problems Conjunctivitis (1784); Headache (1880); Choking (2464); Unspecified Respiratory Problem (4464); Unspecified Eye / Vision Problem (4471); Skin Disorders (4543)

Event Date 07/13/2023

Event Type  Injury  

Event 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.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• Brand Name: REMSTAR AUTO P-FLEX
• 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: 18902303
• MDR Text Key: 337636078
• Report Number: 2518422-2024-13834
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959031159
• UDI-Public: 00606959031159
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 568P
• Device Catalogue Number: 568P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/20/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1973-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other