INFANT RESCUSITATION BAG 10-55203

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for INFANT RESCUSITATION BAG 10-55203 manufactured by Mercury Medical.

Event Text Entries

[16357222] Two day old infant being manually rescsusitated during circuit change out of ventilator. Respiratory therapist noticed that the bag was mal-functioning. The pop off safety valve was inserted at an angle and was not functioning. Device labeled for single use. Patient medical status prior to event: critical condition. There was not 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. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, mechanical tests performed, visual examination. Results of evaluation: manufacturing, valve - relief. Conclusion: device failure occurred and was related to event, device failure directly contributed to event, device was out of spec in a manner that relates to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service, inserviced by manufacturer/distributor representative. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9067
• MDR Report Key: 9067
• Date Received: 1994-07-29
• Date of Report: 1994-04-20
• Date of Event: 1994-04-08
• Date Facility Aware: 1994-04-08
• Report Date: 1994-04-20
• Date Reported to Mfgr: 1994-04-08
• Date Added to Maude: 1994-11-23
• 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

• Brand Name: INFANT RESCUSITATION BAG
• Generic Name: CPR BAG
• Product Code: LYM
• Date Received: 1994-07-29
• Catalog Number: 10-55203
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 8727
• Manufacturer: MERCURY MEDICAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-07-29