RESMED *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-11 for RESMED * manufactured by Resmed.

Event Text Entries

[17108604] The unit smelled of burned wire. Medical co said to call resmed. Resmed said it would take 4 to 6 weeks for some one to contact me and to use the unit. Why recall if it takes so long to replace it?
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1042871
• MDR Report Key: 853167
• Date Received: 2007-05-11
• Date of Report: 2007-05-11
• Date Added to Maude: 2007-05-22
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RESMED
• Generic Name: *
• Product Code: NHJ
• Date Received: 2007-05-11
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 839140
• Manufacturer: RESMED
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2007-05-11