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

Model Number	DEX400S13
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Headache (1880); Dizziness (2194); Cough (4457); No Clinical Signs, Symptoms or Conditions (4582); Eye Irritation (4803)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.There was no report of patient harm or injury.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 allegation of 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.
Additional Manufacturer Narrative
The manufacturer was previously received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.There was no report of patient harm or injury.In previous report, section b5 was mentioned incorrectly.Correct b5 should be - 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 visualization of particles, headache, coughing, dizziness and eye irritation.There was no report of serious or permanent patient harm or injury.The device was returned to an authorized service center for evaluation.The device was visually inspected.The service center found no evidence of sound abatement foam degradation.The device passed all final testing.The manufacturer concludes there was no evidence of sound abatement foam degradation.

• Brand Name: DREAMSTATION CPAP PRO, GER
• 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 15206 ; 2673970028
• MDR Report Key: 12384785
• Report Number: 2518422-2021-03559
• Device Sequence Number: 11730931
• Product Code: BZD
• UDI-Device Identifier: 00606959024083
• UDI-Public: 00606959024083
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DEX400S13
• Device Catalogue Number: DEX400S13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 03/31/2023
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 09/15/2021; 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2019
• 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
• Patient Sex: Unknown