METASCOPE II *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-09-19 for METASCOPE II * manufactured by Colorado Medtech, Inc..

Event Text Entries

[70982] The mixing chamber placed in the ventilator inspiratory line to stabilize f102 source leaked. This prevented the pt from receiving the full ventilator volume. The pt needed to be manually ventilated. The caregiver tried using a second mixing chamber with the device and it leaked as well. Again, the pt needed to be manually ventilated. The ventilator did alarm during the incident. The pt was not injured.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1718663-1997-00001
• MDR Report Key: 120996
• Report Source: 05,06
• Date Received: 1997-09-19
• Date of Report: 1997-09-12
• Date of Event: 1997-09-09
• Date Mfgr Received: 1997-09-12
• Device Manufacturer Date: 1994-05-01
• Date Added to Maude: 1997-09-22
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 3
• Remedial Action: RB
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: METASCOPE II
• Generic Name: METABOLIC PULMONARY-FUNCTION DATA CALCULATOR
• Product Code: BZC
• Date Received: 1997-09-19
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 118586
• Manufacturer: COLORADO MEDTECH, INC.
• Manufacturer Address: 6175 LONGBOW DR. BOULDER CO 80301 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-09-19