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

Model Number	DEX700S13
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Code	Skin Disorders (4543)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a bilevel positive airway pressure (bipap) device's sound abatement foam became degraded and the patient developed a skin disease.The details of the patient's required medical intervention are unknown.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 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 previously reported an allegation of an issue related to sound abatement foam and became degraded and caused the patient to developed a skin disease.The medical intervention that the patient received in response to the event is currently unknown.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.
Additional Manufacturer Narrative
Sections b1, b2, h1, h6 have been corrected in this report as follows: section b1 was corrected for product problem.(both the product problem and adverse event was checked in the previous mdr.) section b2 was corrected to blank.(previously, it was other serious or important medical events.) section h1 was changed from serious injury to malfunction.Section h6 health effects: impact code was updated.
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 previously reported an allegation of an issue related to a cpap device's sound abatement foam.The manufacturer received information alleged sound abatement foam became degraded and caused the patient to developed a skin disease.The device was returned to the third party service center for further evaluation.The device was evaluated.There was no mention of visual findings to the external part of the device.The internal aspect of the device was inspected and dust contamination was found.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed.There were two errors found.The third party service center concludes that they could not confirm the customer's allegation and there was no visible foam degradation and unit was scrapped.Section h6 updated in this report.

• Brand Name: DREAMSTATION AUTO BIPAP, 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: melissa rosko ; 6501 living place; pittsburgh, PA 15206 ; 7243512041
• MDR Report Key: 12322515
• Report Number: 2518422-2021-02983
• Device Sequence Number: 11858965
• Product Code: BZD
• UDI-Device Identifier: 00606959024106
• UDI-Public: 00606959024106
• 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,Followup,Followup
• Report Date (Section B): 12/18/2024

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: DEX700S13
• Device Catalogue Number: DEX700S13
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 03/17/2023; 09/03/2024; Not provided
• Initial Report FDA Received Date: 08/15/2021
• Supplement Report FDA Received Date: 09/10/2021; 08/31/2023; 12/18/2024; 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2016
• 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