MAUDE Adverse Event Report: RESMED RESMED CPAP; CPAP MACHINE

Device Problem Device Disinfection Or Sterilization Issue (2909)

Patient Problems Cellulitis (1768); Respiratory Tract Infection (2420)

Event Date 10/30/2015

Event Type  Injury  

Event Description

I use a sinupulse elite nasal wash system and a resmed cpap with an integrated humidifier.I use distilled water in both devices.I have been using the sinupulse for about 2 years and the cpap for about 6 months.I suddenly developed a sinus infection which completely closed my eye.I was rushed to the emergency room and admitted to the hospital.I had two emergency surgeries on my eye and sinuses (two surgical teams at the same time).The drainage was cultured and determined to be pseudomonas.I had no recent procedures or hospitalizations.The diagnosis was orbital cellulitis/abcess and sinusitis caused by pseudomonas.Neither the sinupulse or resmed cpap warned of this possibility or discussed how to disinfect their machines.I used distilled water in both machines.

• Brand Name: RESMED CPAP
• Type of Device: CPAP MACHINE
• Manufacturer (Section D): RESMED
• MDR Report Key: 5305985
• MDR Text Key: 33853433
• Report Number: MW5058551
• Device Sequence Number: 2
• Product Code: BZD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/14/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 87 YR
• Patient Weight: 54