MAUDE Adverse Event Report: PHILIPS RESPIRONICS, INC. REMSTAR PRO C-FLEX+; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number IN461S

Device Problem Degraded (1153)

Patient Problems Abscess (1690); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Headache (1880); Red Eye(s) (2038); Aphonia (4409); Swelling/ Edema (4577)

Event Date 09/07/2022

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 manufacturer received information alleging an issue related to a cpap device's sound abatement foam became degraded and caused dysphagia, aphonia, abcess of the soft palate, pharyngitis, respiratory distress, uvula edema, migraines and eye redness.The patient did report to receive medical intervention and was hospitalized, had surgery and has saw a specialist.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

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 manufacturer received information alleging an issue related to a cpap device's sound abatement foam became degraded and caused dysphagia, aphonia, abcess of the soft palate, pharyngitis, respiratory distress, uvula edema, migraines and eye redness.The patient did report to receive medical intervention and was hospitalized, had surgery and has saw a specialist.Despite multiple attempts on (b)(6) 2022, 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.Section h6 updated in this report.

Manufacturer Narrative

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 manufacturer received information alleging an issue related to a cpap device's sound abatement foam became degraded and caused dysphagia, aphonia, abscess of the soft palate, pharyngitis, respiratory distress, uvula edema, migraines and eye redness.The patient did report to receive medical intervention and was hospitalized, had surgery and has saw a specialist.Despite the three attempts (b)(6) 2022 to have the device returned for evaluation and investigation were unsuccessful.The device has not yet been 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.

• Brand Name: REMSTAR PRO C-FLEX+
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 15447681
• MDR Text Key: 300163400
• Report Number: 2518422-2022-81645
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959030251
• UDI-Public: 00606959030251
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IN461S
• Device Catalogue Number: IN461S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other