MAUDE Adverse Event Report: RESMED CORP. RESMED 11; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Low Oxygen Saturation (2477); Weight Changes (2607)

Event Description

Reporter states that since she has began using the resmed 11 cpap she feels worse than she did when she used her dreamstation and that she is no longer able to use the old cpap because it was returned due to it being recalled.She has had fluid retention weight gain, headaches, oxygen saturation at 89%.She has been told that her o2 sat is low because of the altitude of where she lives.Reporter states that she has been in contact with the distributor (b)(4) and her respiratory therapist.Reporter states that the respiratory therapist programed the setting on the cpap and she believes that the cpap is recording erroneous results.She has had several overnight sleep studies, map test and doctors appointments her expense.After has completed her studies, the respiratory therapist has not changed her prescribed orders and as of now will not return her calls.Reporter states that she feels like no one is listing and that she does not trust the cpap industry.

• Brand Name: RESMED 11
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 15348866
• MDR Text Key: 299310004
• Report Number: MW5111859
• 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
• Type of Report: Initial
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1