MAUDE Adverse Event Report: PHILIPS RESPIRONICS, INC. DREAMSTATION AUTO CPAP, GER; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	DEX500S13
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Cough (4457); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Eye Irritation (4803)
Date of Event	08/19/2021
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 the patient to have sinus problems.The patient did receive medical intervention in the form of a paranasal surgery for sinus issues.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 sound abatement foam.This action was reported to the fda per 21 cfr part 806.The device will be corrected per res 88058.Corrected data: d8 was this device serviced by a third party?: previously reported as no; updated to unknown.E1 initial reporter contact (name): previously reported as (b)(6); updated to unknown.E1 address: e1 phone numbers: previously reported as (b)(6); updated to unknown.
Additional Manufacturer Narrative
The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused the patient to have nasal congestion, coughing, mucus, eye irritation and sinus problems.The patient did receive medical intervention in the form of a paranasal surgery for sinus issues.The device is not returning to the manufacturer for evaluation.The manufacturer received information on may 24, 2022 stating the patient's lawyer refuses to release the device 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: DREAMSTATION AUTO CPAP, GER
• Common Device Name: 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: 12388881
• Report Number: 2518422-2021-03445
• Device Sequence Number: 17347206
• Product Code: BZD
• UDI-Device Identifier: 00606959024090
• UDI-Public: 00606959024090
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2022

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: DEX500S13
• Device Catalogue Number: DEX500S13
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 05/24/2022
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 09/16/2021; 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2017
• 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
• Usage of Device: Unknown
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DREAMSTATION HUMIDIFIER (SN (B)(6))
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown