*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-04-13 for * manufactured by *.

Event Text Entries

[133636] L. V. N. Came on duty at 0700. Pt's lungs were congested. She gave pt a bath, & changed the adhesive tape which kept the phrenic nerve stimulator in place. Pulse oximeter alarmed & o2 saturation went from 96% to 86% within a few seconds. No pulse at this time. 0820 911 called & cpr started.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 162738
• MDR Report Key: 162738
• Date Received: 1998-04-13
• Date of Report: 1998-04-10
• Date of Event: 1998-04-03
• Date Facility Aware: 1998-04-03
• Report Date: 1998-04-10
• Date Added to Maude: 1998-04-17
• 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: 0
• 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: PHRENIC NERVE STIMULATOR
• Product Code: GZE
• Date Received: 1998-04-13
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 158446
• Manufacturer: *
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death; 2. Other; 3. Deathisabilit	1998-04-13