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

Model Number DSX700H11C

Device Problem Degraded (1153)

Patient Problems Cyst(s) (1800); Dry Eye(s) (1814); Dyspnea (1816); Pulmonary Emphysema (1832); Nasal Obstruction (2466); Unspecified Respiratory Problem (4464); Eye Pain (4467)

Event Date 03/01/2021

Event Type  Death  

Event Description

The manufacturer received information alleging a bipap device's sound abatement foam became degraded and caused no tears, emphysema, nose obstruction.The patient did receive medical intervention and reported to have a surgical procedure, insertion of eye plugs, bronchoscopy, lab work and saw a pulmonary specialist.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

Additional innformation has been received and section b5 has been corrected/updated as: 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 a bipap device's sound abatement foam became degraded and caused no tears, emphysema, nose obstruction.The patient did receive medical intervention and reported to have a surgical procedure, insertion of eye plugs, bronchoscopy, lab work and saw a pulmonary specialist.The patient had pain, shortness of breath, bone spur-obstruction, kidney cyst and dry eyes.The patient underwent multiple surgeries in response to the reported event.The patient has passed away.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.The following correction has been updated in this report.Section b1 has been updated to reflect as adverse event.Section b2 has been updated to reflect as death.Section h1 and h6 has been also been updated to reflect the death.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.  additional information was received and section b5 should be reported as:   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 an issue related to a cpap device's sound abatement foam.The patient alleged to experience pain and lack of right breathing to pulmonary, surgery to remove a nasal, bone spur obstruction (non-cancer), kidney cyst, dry eyes for which 2 sets of tear eye plugs are inserted every 6 months, bronchoscopy lung scrape for emphysema, and double hernia repair from the device.There was no medical intervention required by the patient.The reported event and its reported severity was reviewed by the manufacture's clinical expert.This event is assessed as not related to the device in this case.Based on the available information, the manufacture concludes no further action is necessary.There was no medical intervention required by the patient.  the device has not yet returned to the manufacturer for evaluation.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 at this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

The manufacturer previously submitted mdr 2518422-2021-07487-1 with incorrect sections b1, b2, h1, h6.Corrections to previous mdr are made in this report as follows.Section b1 was corrected to adverse event and product problem.(only product problem was checked in previous mdr).Section b2 was corrected to other serious or important medical events.(previously it was blank).Section h1 was changed from malfunction to serious injury.Section h6- health impact code was updated.

• Brand Name: DREAMSTATION AUTO BIPAP
• 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: 12910000
• MDR Text Key: 281523012
• Report Number: 2518422-2021-07487
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959025691
• UDI-Public: 00606959025691
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX700H11C
• Device Catalogue Number: DSX700H11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2019
• 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): Death; Other; Hospitalization; Required Intervention