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

Model Number DSX500H11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Dyspnea (1816); Urinary Tract Infection (2120); Low Oxygen Saturation (2477); Unspecified Kidney or Urinary Problem (4503); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/11/2021

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, and mechanical ventilator devices.The manufacturer received information alleging pancreas problem, kidneys problem, difficulty in breathing, low oxygen getting.There was no report of serious or permanent patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.A correction to b5 was made and 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 previously received information alleging small tumour in left kidney and pancreas, difficulty in breathing, low oxgen getting and bladder infection.Patient will be under going surgery on (b)(6) 2021.The device was returned to the product investigation laboratory for further evaluation.The device was evaluated.An external investigation found indeterminate dust/dirt contamination under both sd cover and accessory module flip doors, at the iso port entrance, and at the air inlet where a filter would normally otherwise be.The manufacturer performed an interior investigation and found an unknown white colored dust contaminant observed on blower motor casing and blower motor impeller.Mineral spots consistent with water ingress were found on the motor casing.A keratin-like substance was observed around the blower box outlet.There were dark colored particles found in the bottom enclosure and on rear panel interior around the iso port.The manufacturer trued to power on the device power but a service required message was generated.The manufacturer confirmed the presence of degraded sound abatement foam.The device's downloaded logs were reviewed by the manufacturer.There was twenty six errors found.The manufacturer concludes that they could not confirm the customer's symptoms allegation and there was visible foam degradation.Section(s) b1 and b2, has changed related to the complaint changing from the product problem to reported adverse event.Section h1 has changed to reflect a serious injury.Section h6 health effect- clinical code has been corrected (missed to capture all relevant codes) section h6 updated in this report.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: 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: 15377623
• MDR Text Key: 303234065
• Report Number: 2518422-2022-78368
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500H11C
• Device Catalogue Number: DSX500H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2020
• 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; Other