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

Model Number DSX600H11C

Device Problem Degraded (1153)

Patient Problems Unspecified Infection (1930); Nausea (1970); Pain (1994); Vertigo (2134); Depression (2361); Cough (4457)

Event Date 10/05/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging a bipap device's sound abatement foam became degraded and caused pain, eye irritation, cough, vertigo, nausea, infection, sore throat and depression.The patient did receive medical intervention and has reported to have seen multiple doctors, had a ct scan done, on antibiotics and getting allergy shots.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

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 biphasic positive airway pressure (bipap) device's sound abatement foam became degraded and caused pain,eye irritation, cough, vertigo, nausea, infection, sore throat and depression.The patient did receive medical intervention and has reported to have seen multiple doctors, had a ct scan done, on antibiotics and getting allergy shots.The reported event of eye irritation, cough, vertigo, nausea, infection, sore throat and depression 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 and at this time, no further investigation can be performed.Ifany 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.Section h6 health effect- impact code, type of investigation findings and investigation conclusions has been updated.

Manufacturer Narrative

The manufacturer previously submitted mdr 2518422-2021-08065 -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 BIPAP PRO
• 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: 12984248
• MDR Text Key: 282114439
• Report Number: 2518422-2021-08065
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX600H11C
• Device Catalogue Number: DSX600H11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2018
• 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): Required Intervention; Other