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

Model Number	GBX400S15
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Headache (1880); Hearing Impairment (1881); Burning Sensation (2146); Sore Throat (2396); Choking (2464); Abdominal Distention (2601); Unspecified Blood or Lymphatic problem (4434); Heart Failure/Congestive Heart Failure (4446); Cough (4457); Unspecified Eye / Vision Problem (4471); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582); Hypokalemia (4825); Sinusitis (4844); Pelvic Pain (4865); Back pain (4895)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
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.Section h1 has been corrected to reflect the information reported in b2 and "malfunction" was accuratley checked in section h1.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 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 diabetes and stages of heart failure.Patient also alleged of having headaches, hearing difficulties, itchy skin, worsening symptoms of breathlessness, discomfort from lower back pain, swollen stomach, sore throat, sinuses, congestive pain, edema and low potassium, fatigue, feeling choked, erratic reading of blood sugar, eyes and hearing are bad, productive cough, tongue and throat felt burned.The sections b1, b2, h1, h6 have been corrected in this report as follows: section b1 was corrected to adverse event and product problem (product problem was checked in the previous mdr).Section b2 was made other serious (previously it was blank).Section h1 was changed from malfunction to serious injury.Section h6 code health effect - clinical codes and health effect- impact code was corrected.

• Brand Name: DREAMSTATION CPAP PRO, GB
• 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: rosko melissa ; 6501 living place; pittsburgh, PA 15206 ; 7243512041
• MDR Report Key: 12754734
• Report Number: 2518422-2021-06213
• Device Sequence Number: 13800095
• Product Code: BZD
• UDI-Device Identifier: 00606959023482
• UDI-Public: 00606959023482
• 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): 12/23/2024

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: GBX400S15
• Device Catalogue Number: GBX400S15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 04/27/2022; 11/22/2024
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 04/29/2022; 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown