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

Model Number	REF 36995
Health Effect - Clinical Codes	Headache (1880); Nausea (1970); Blister (4537)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Blisters in throat, headache; resmed sleep apnea climateline tubing ref-36995 made in (b)(4).Lot: 1553562, sn: (b)(4), brand new tubing has heavy chemical smell used for several days thinking it would stop.Got a replacement and it was the same thing.Can't use, it makes me nauseous.Fda safety report id# (b)(4).

• Brand Name: CLIMATELINE TUBING
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 12878185
• Report Number: MW5105595
• Device Sequence Number: 4949562
• Product Code: BZD
• UDI-Device Identifier: 00619498369959
• UDI-Public: (01)00619498369959
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: REF 36995
• Device Catalogue Number: 36995
• Device Lot Number: 1553562
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/24/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: B12; CALCIUM; VIT C; VIT D
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White