DRAGER BABYLOG 8000 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-09-17 for DRAGER BABYLOG 8000 * manufactured by Drager, Inc / Critical Care Systems.

Event Text Entries

[137624] With power outage/surge and restart, ventilator mode was changed from simv to imv (from english version to foreign language) factory default settings rather than previous pt settings. ) the pt was able to breathe independently of vent-cycled breaths though without synchronization, thereby causing increased work of breathing by the pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 240589
• MDR Report Key: 240589
• Date Received: 1999-09-17
• Date of Report: 1999-09-16
• Date of Event: 1999-09-10
• Date Facility Aware: 1999-09-10
• Report Date: 1999-09-16
• Date Reported to FDA: 1999-09-16
• Date Reported to Mfgr: 1999-09-16
• Date Added to Maude: 1999-09-21
• 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
• Reporter Occupation: RESPIRATORY THERAPIST
• 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: DRAGER BABYLOG
• Generic Name: VENTILATOR
• Product Code: FOD
• Date Received: 1999-09-17
• Model Number: 8000
• Catalog Number: *
• Lot Number: *
• ID Number: PART # 8410280
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 3 YR
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 233115
• Manufacturer: DRAGER, INC / CRITICAL CARE SYSTEMS
• Manufacturer Address: 4101 PLEASANT VALLEY RD STE 100 CHANTILLY VA 20151 US
• Baseline Brand Name: UMBILICAL CORD CLAMP
• Baseline Generic Name: UMBILICAL CORD CLAMP
• Baseline Model No: NA
• Baseline Catalog No: 6833-B
• Baseline ID: NA
• Baseline Device Family: UMBILICAL OCCLUSION DEVICE
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1999-09-17