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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL ICON; CPAP
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FISHER & PAYKEL ICON; CPAP Back to Search Results
Model Number ICON AUTO
Device Problems Device Remains Activated (1525); Structural Problem (2506); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/15/2015
Event Type  malfunction  
Event Description
I have a cpap therapy machine made by fisher and paykel.The machine has no on/off switch.It is in "standby" all the time.However, the machine gets very hot even when in standby.The machine has a facility for heated water being used to humidify the air being provided to the pt during the therapy time.It is unclear if the heater doesn't go off, or there is some other problem.I have been given several different stories from fisher and paykel without any solution.Fisher and paykel has told me that if i'm concerned, the machine should just be unplugged when not in use.However, this kills the time/date functions in the machine rendering the reporting system unusable.Compliance reporting for cpap therapy is a very important part of the treatment.These machines are often installed in a drawer next to the bed - trapping the heat and making them very unsafe.I regard this as a serious design defect in the fisher and paykel machines.
 
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Brand Name
ICON
Type of Device
CPAP
Manufacturer (Section D)
FISHER & PAYKEL
MDR Report Key5341307
MDR Text Key35057649
Report NumberMW5058856
Device Sequence Number1
Product Code BZD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/29/2015
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
Device Operator Lay User/Patient
Device Model NumberICON AUTO
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/29/2015
Type of Device Usage N
Patient Sequence Number1
Patient Age60 YR
Patient Weight116
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