DISPOSABLE PEDIATRIC AMBU BAG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-19 for DISPOSABLE PEDIATRIC AMBU BAG manufactured by Mapleson-vital Signs, Inc..

Event Text Entries

[2406] Patient was manually being ventilated with vital signs, inc. Anesthesia bag. Manual ventilation was to be decreased. As this was adjusted the relief valve on ambu bag filled with oxygen gas. Chest x-ray performed. No patient injury deletedinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3020
• MDR Report Key: 3020
• Date Received: 1992-08-19
• Date of Event: 1991-12-11
• Date Facility Aware: 1991-12-11
• Date Reported to Mfgr: 1991-12-19
• Date Added to Maude: 1993-04-05
• 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: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Generic Name: DISPOSABLE PEDIATRIC AMBU BAG
• Product Code: KNE
• Date Received: 1992-08-19
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 2823
• Manufacturer: MAPLESON-VITAL SIGNS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-08-19