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

Model Number DSX500T11

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Asthma (1726); Cancer (3262)

Event Date 01/03/2021

Event Type  Death  

Event Description

In 2020, (b)(6) began suffering with adult onset asthma and seeing a pulmonologist who was concerned about the severity of the asthma and the unknown cause and late onset of the asthma.He was receiving asthma injections of xolair that were very expensive and not very effective.In (b)(6) 2021, (b)(6) was diagnosed with pancreatic cancer.Both of these conditions have been discussed in the recall of the philips cpap machine that he had been using since (b)(6) 2018.I am concerned that the philips cpap machine may have contributed to his death on (b)(6) 2021.Passed away from pancreatic cancer on (b)(6) 2021.Fda safety report id # (b)(4).

• Brand Name: PHILIPS DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12860879
• MDR Text Key: 281198836
• Report Number: MW5105505
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: NONE - DECEASED
• Patient Outcome(s): Other; Death
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White