MAUDE Adverse Event Report: RESPIRONICS INC REMSTAR PRO C-FLEX + SYSTEM ONE 60 SERIES GB; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	GB461S
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Arrhythmia (1721); Chest Pain (1776); Dry Eye(s) (1814); Dyspnea (1816); Fatigue (1849); Headache (1880); Liver Damage/Dysfunction (1954); Nausea (1970); Visual Impairment (2138); Dizziness (2194); Low Oxygen Saturation (2477); Cough (4457); Unspecified Respiratory Problem (4464); Eye Infections (4466); Dry Mouth (4485); Renal Impairment (4499)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused hypersensitivity and inflammatory responses,chest pressure and chest pain, coughing and unexplained breathlessness.Additionally, kidney and liver dysfunction and low blood oxygen levels.The patient did receive medical intervention with prescription medications for the chest pain when in the emergency room.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleged dizziness, nausea, headaches, dry mouth, eye irritation, decrease vision.Despite multiple attempts, the device has not yet returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Codes in section h6, date of event in section b3, address in section e1 were updated or corrected.
Event or Problem Description
The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused hypersensitivity and inflammatory responses,chest pressure and chest pain, coughing and unexplained breathlessness.Additionally, kidney and liver dysfunction and low blood oxygen levels.The patient did receive medical intervention with prescription medications for the chest pain when in the emergency room.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer previously reported an issue related to sound abatement foam.This action was reported to fda per 21 cfr part 806.The device will be corrected per res 88058.

• Brand Name: REMSTAR PRO C-FLEX + SYSTEM ONE 60 SERIES GB
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15568
• 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: 12471842
• Report Number: 2518422-2021-03689
• Device Sequence Number: 19806089
• Product Code: BZD
• UDI-Device Identifier: 00606959030329
• UDI-Public: 00606959030329
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2022

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: GB461S
• Device Catalogue Number: GB461S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 04/21/2022
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 11/09/2021; 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2014
• 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: RES 88058
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male