MAUDE Adverse Event Report: RESMED / MEIBAN MICRO PTE LTD CLIMATELINE AIR 11; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number RS11

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 07/02/2022

Event Type  malfunction  

Event Description

Resmed sense 11; sn: (b)(4); ref: 39420; lot: 1518062 stops putting air out.None of the water in the humidifier was used.Machine starts as usual then stops., sleep disrupted.Took off mask, no air coming out of mask.Put it back on.No air coming through.Used start button, air came through for about 4 seconds then stopped.This has occurred 3 times in the last 2 months.Fda safety report id# (b)(4).

• Brand Name: CLIMATELINE AIR 11
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED / MEIBAN MICRO PTE LTD
• MDR Report Key: 14946350
• MDR Text Key: 295499711
• Report Number: MW5110715
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00619498394203
• UDI-Public: 00619498394203
• 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
• Report Date: 07/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RS11
• Device Catalogue Number: 39420
• Device Lot Number: 1518062
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: HEARING AIDES; MULTIPLE MEDS
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White