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

Model Number DS960HS

Device Problem Degraded (1153)

Patient Problems Apnea (1720); Dyspnea (1816); Pneumonia (2011)

Event Date 07/26/2022

Event Type  malfunction  

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, bipap and mechanical ventilator devices.The manufacturer received information alleging difficulty in breathing and obstructive apnea.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.Additional information was received and section 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 issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleged difficulty in breathing and obstructive apnea and pneumonia.There was no medical intervention required by the patient.The reported event difficulty in breathing and obstructive apnea and pneumonia and its reported severity was reviewed by the manufacture's clinical expert.This event is assessed as related to the device in this case.Based on the available information, the manufacture concludes 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.Section(s) has changed related to the complaint changing from the reported product problem to an adverse event.Section has changed to reflect a serious injury.Updated in this report.

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 an issue related to a bilevel positive airway pressure (bipap) device's sound abatement foam.The patient alleged to experience lung infection.There was no medical intervention required by the patient.The reported event of  lung infection 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. section(s) 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
• 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: 15221764
• MDR Text Key: 301646035
• Report Number: 2518422-2022-66130
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959012523
• UDI-Public: 00606959012523
• 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: 02/05/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: DS960HS
• Device Catalogue Number: DS960HS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2022
• Initial Date FDA Received: 08/12/2022
• Supplement Dates Manufacturer Received: 05/15/2023; 01/09/2024
• Supplement Dates FDA Received: 07/03/2023; 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2015
• 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