MAUDE Adverse Event Report: PHILIPS/RESPIRONICS, INC DREAMSTATION CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX500H11C

Device Problem Nonstandard Device (1420)

Patient Problems Fall (1848); Hemorrhage/Bleeding (1888); Dizziness (2194); Cough (4457); Intervertebral Disc Compression or Protrusion (4524); Nodule (4551)

Event Date 11/01/2021

Event Type  Injury  

Event Description

Reporters mother had coughing and dizziness starting in (b)(6) 2021, she took her mother to the doctor, and all of her test results came back normal.On (b)(6) 2022, the reporters mother had dizziness and fell; 911 was called."once at the hospital test results revealed ruptured dics in her back without scarring, brain bleed and nodes in the lungs.¿fda website says continue to use the cpap machine although it has been recalled.I would have never subjected my mother to use this device i had known it would cause cancer.I have contacted philips spoke to (b)(6).He would not give me his full name and he could only tell me that my mother¿s new cpap would arrive between now and (b)(6) 2022.This is not a reasonable time frame to issue a new device.¿.

• Brand Name: DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC
• MDR Report Key: 14160518
• MDR Text Key: 289781326
• Report Number: MW5109158
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/18/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: DSX500H11C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Race: White