*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-09-30 for * manufactured by Smiths Medical Md Inc..

Event Text Entries

[412404] In 2005 at 2:30 pm patient was snoring loudly and unable to respond to verbal stimulus. Pca was stopped, narcan was administered and 100% oxygen delivery. Patient immediately responded. Vital signs at time of discovery: bp 139/69, hr 103, pulse ox 83% rr10. Post treatment bp 110/60, hr 80, pulse ox 99% rr16. Patient discharged as expected the next day.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 639716
• MDR Report Key: 639716
• Date Received: 2005-09-30
• Date of Report: 2005-09-09
• Date of Event: 2005-06-17
• Date Facility Aware: 2005-06-17
• Report Date: 2005-09-09
• Date Reported to Mfgr: 2005-08-02
• Date Added to Maude: 2005-10-07
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• 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: *
• Generic Name: PATIENT CONTROLLED ANALGESIA DEVICE
• Product Code: LDR
• Date Received: 2005-09-30
• Returned To Mfg: 2005-08-02
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 629246
• Manufacturer: SMITHS MEDICAL MD INC.
• Manufacturer Address: 1265 GREY FOX ROAD ST. PAUL MN 55112 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2005-09-30