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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Unspecified Respiratory Problem (4464); Dry Mouth (4485)

Event Date 11/12/2022

Event Type  Injury  

Event Description

The res-med c-pap s/n (b)(4) did not heat the water chamber resulting in severe dryness of the entire mouth and throat.I've not been able to use the unit ever since.Fda safety report id #(b)(4).

Event Description

Additional information received for report mw5113588 on 12/9/2022 to make manufacturer resmed corp.

• Brand Name: RES-MED
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 15906246
• MDR Text Key: 304845627
• Report Number: MW5113588
• 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,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/29/2022
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White