MAX 02 404-001-801 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-03 for MAX 02 404-001-801 N/A manufactured by Mountain Medical Equipment.

Event Text Entries

[20681491] An elderly 70 year old male received 2nd and 3rd degree burns on the upper portion of his body due to smoking while using home oxygen therapy. The patient was receiving oxygen from an oxgenn concentrator via nasal cannula delivery system. He removed the nasal cannula from his nose to his chin. He attempted to light a cigar when the opened flame cause the oxygen from the nasal cannula to combust. This action caused the patient to receive 2nd degree burns on his lips, nose right cheek, head, palm of his hand, the right side of his neck and upper chest. The patient received 3rd degree burns on the upper lip and right hand. The patient was taken to the emergency department at the denver va medical center where he was bandaged for his condition. The patient was using the oxygen concentrator with disposable single patient nasal cannula w/ 7ft. Attached tubing, over the ear style;disposable single patient use oxygen connecting tubing, 25 ft. Long, vinyl, 3 channel tubing and the disposable single patient use bubble humidifier. All of these products were manufactured by salter labs and packaged for trail ridge products, inc. The company was notified and the oxygen concentrator was returned to mountain medical for manufactuers evaluationdevice labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-sep-92. Service provided by: user facility biomedical/bioengineering department. Service records available. Imminent hazard to public health claimed. Device not used as labeled/indended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, other, other, invalid data. Results of evaluation: invalid data, invalid data. Conclusion: no failure detected and product within specification, user error caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: user education provided, invalid data. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 33327-1992-00001
• MDR Report Key: 1715
• Date Received: 1992-11-03
• Date of Report: 1992-10-23
• Date of Event: 1992-09-29
• Date Facility Aware: 1992-09-29
• Report Date: 1992-10-23
• Date Reported to FDA: 1992-10-23
• Date Reported to Mfgr: 1992-10-09
• Date Added to Maude: 1992-11-13
• Event Key: 0
• Report Source Code: Distributor 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: UNKNOWN
• 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: MAX 02
• Generic Name: OXYGEN CONCENTRATOR
• Product Code: BYF
• Date Received: 1992-11-03
• Model Number: 404-001-801
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: N/A
• Operator: OTHER CAREGIVERS
• Device Availability: Y
• Device Age: 01-SEP-85
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1621
• Manufacturer: MOUNTAIN MEDICAL EQUIPMENT

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-11-03