* M1016A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-10 for * M1016A manufactured by Hewlett-packard Co..

Event Text Entries

[102719] Co2 monitor needed to assist in determining et tube placement during emergency intubation. Monitor did not work. Proper tube placement determined by ausculation of breath sounds. No harm to pt, but evaluation not optimal. Monitor sent to bioengineering for evaluation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1012341
• MDR Report Key: 127927
• Date Received: 1997-10-10
• Date of Report: 1997-09-30
• Date of Event: 1997-09-18
• Date Added to Maude: 1997-10-27
• 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: 0
• Reporter Occupation: RESPIRATORY THERAPIST
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: C02 MONITOR
• Product Code: CCC
• Date Received: 1997-10-10
• Model Number: M1016A
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 125175
• Manufacturer: HEWLETT-PACKARD CO.
• Manufacturer Address: 3000 MINUTEMAN RD ANDOVER MA 018101099 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1997-10-10