MAUDE Adverse Event Report: PHILLIPS RESPIRONICS / RESPIRONICS, INC. DREAMWEAR MASK BUNDLE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number J301841937E85

Device Problems Nonstandard Device (1420); Device Emits Odor (1425); Failure to Shut Off (2939)

Patient Problems Dyspnea (1816); Headache (1880)

Event Date 05/10/2021

Event Type  Injury  

Event Description

Phillips respironics dream station auto with heated humidifier: device ran out of water but failed to stop running humidifier (included instructions state the humidifier function shuts off if it runs dry).Woke to burning smell and realized i hadn't dreamed the smell but couldn't wake enough to realize the danger of the situation.Device could have caught fire.Also from beginning of use i had daily headaches and began noticing breathing issues.I have asthma so i attributed the worsening condition to the asthma.Since (b)(6) i have been trying unsuccessfully to get my money returned for this defective and dangerous device.(b)(6) refused a refund stating phillips was handling refunds due to the recall.I have made numerous contacts.I am always told an escalation form is being completed and i will be contacted.It is now (b)(6) and no one has ever made an effort to update me or get me a mailer and shipping label and a refund.First available pulmonary function test is (b)(6) 2022.Fda safety report id # (b)(4).

• Brand Name: DREAMWEAR MASK BUNDLE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILLIPS RESPIRONICS / RESPIRONICS, INC.
• MDR Report Key: 12835285
• MDR Text Key: 281020547
• Report Number: MW5105411
• Device Sequence Number: 2
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/15/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: J301841937E85
• Device Catalogue Number: REF1116700
• Device Lot Number: 0301854396
• Patient Sequence Number: 1
• Treatment: B-COMPLEX ; FISH OIL ; MULTI VITAMINS ; SINGULAIR ; VITAMIN C ; XYZAL
• Patient Outcome(s): Disability
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White