UNK UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-01-28 for UNK UNKNOWN manufactured by Unknown.

Event Text Entries

[149] Patient found by ems to be in full arrest. Patient intubated with size 8. 0 ett which had been checked per protocol prior to insertion. In route to facility, it was determined ventilatory efforts were being hampered due to inadequately sealed airway, endotracheal tube replaced. Original tube checked after removal from patient and it was found that the cuff would not inflate. Relevant devices in use at the time includes, bag valve mask-pulmonez brand manufactured by life design systems. Seriesdevice 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, performance tests performed. Results of evaluation: other. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 228
• MDR Report Key: 228
• Date Received: 1992-01-28
• Date of Event: 1992-01-07
• Date Facility Aware: 1992-01-07
• Date Added to Maude: 1992-04-13
• 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: UNK
• Generic Name: ENDOTRACHEAL TUBE
• Product Code: LNZ
• Date Received: 1992-01-28
• Model Number: UNKNOWN
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 224
• Manufacturer: UNKNOWN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-01-28