MAUDE Adverse Event Report: RESPIRONICS, INC BIPAP AUTOSV ADV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DS960XHS

Device Problem Degraded (1153)

Patient Problems Chronic Obstructive Pulmonary Disease (COPD) (2237); Discomfort (2330); Sore Throat (2396); Cancer (3262); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/30/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The patient alleged brain cancer, copd, nasal/throat irritation or soreness, and cannot swallow.Patient also alleged that the device will not turn on or function.Medical intervention was not specified.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 submitted mdr 2518422-2022-13946-1 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.

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 soundabatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The patient alleged to experience brain cancer, totally disabled, copd, cannot swallow, nasal/throat irritation or soreness, device will not turn on/device not functioning.The patient did not report to receive medical intervention.The reported events of brain cancer, totally disabled, copd, cannot swallow, nasal/throat irritation or soreness, device will not turn on/device not functioning and its reported severity was reviewed by the manufacture's clinical expert.These events were assessed as not related to the device in this case.Based on the available information, the manufacture concludes no further action is necessary.The device has not yet returned to the manufacturer for evaluation and at this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Sections b1, b2 has changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.

• Brand Name: BIPAP AUTOSV ADV
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 14161980
• MDR Text Key: 289674271
• Report Number: 2518422-2022-13946
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959029798
• UDI-Public: 00606959029798
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: DS960XHS
• Device Catalogue Number: DS960XHS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 05/30/2023; 05/30/2023
• Supplement Dates FDA Received: 06/20/2023; 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2016
• 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): Other