MAUDE Adverse Event Report: RESPIRONICS INC DREAMSTATION AUTO BIPAP W/HUM/CELL, DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX700H11C

Device Problem Degraded (1153)

Patient Problems Stroke/CVA (1770); Dyspnea (1816); Cancer (3262); Convulsion/Seizure (4406); Nodule (4551)

Event Date 07/13/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop seizures, strokes, and cancer.There is no report of the medical intervention that the patient has received at this time.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.This action was reported to fda per 21 cfr part 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer was initially 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 patient alleged seizures, strokes, and cancer.There is no report of the medical intervention that the patient has received at this time.In initial reports section b5 mentioned incomplete, correct b5 should be - the patient alleged seizures, strokes, cancer, spot on lungs, shortness of breath.There is no report of the medical intervention that the patient has received at this time.The device was returned to the manufacturer's product investigation laboratory for investigation.An external visual inspection of the device was completed by the manufacturer and found no contamination.An internal visual inspection was completed by the manufacturer and found unknown discoloration on the blower motor.The manufacturer found no evidence of sound abatement foam degradation.The device's downloaded event log was reviewed by the manufacturer and found no errors.The device was applied power and the device operated properly.The manufacturer concludes the device has unknown discoloration on the blower motor.There was no evidence of sound abatement foam degradation.In this report, section d9, g3, h3, h6 has been updated or corrected.

• Brand Name: DREAMSTATION AUTO BIPAP W/HUM/CELL, DOM
• 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: 12300845
• MDR Text Key: 265806771
• Report Number: 2518422-2021-02972
• 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: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• 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?: Device Returned to Manufacturer
• Date Manufacturer Received: 12/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2020
• 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