MAUDE Adverse Event Report: FISHER & PAYKEL CPAP

Model Number ICONPBN

Device Problems Nonstandard Device (1420); Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 08/29/2017

Event Type  malfunction  

Event Description

My wife's cpap machine would not work after a power outage.We looked online for troubleshooting and found a recall for iconpbn by fisher & paykel dated 2013.Serial number (b)(4).She was never notified of this issue.It also looks like the range of products is larger than the recall.

• Brand Name: CPAP
• Type of Device: CPAP
• Manufacturer (Section D): FISHER & PAYKEL
• MDR Report Key: 6838690
• MDR Text Key: 84847989
• Report Number: MW5071901
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ICONPBN
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 113