* 321-7660-980

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-01-09 for * 321-7660-980 manufactured by Ohio Medical Products Div Of Airco, Inc..

Event Text Entries

[241745] Maintenance mechanic was performing a routine preventive maintenance check of oxygen alarm panels throughout facility. Upon checking the panel in bldg 3 basement, recreational therapy computer room, the panel was discovered not functioning. The panel was removed from the wall where it was discovered that all internal components had evidence of being charred and burned. It appeared that one or more components overheated and at some point ignited flame inside the panel enclosure. There is a small diameter plastic tube which brings pure oxygen inside the panel so the oxygen pressure can be sensed and monitored. The tube was not ruptured from the flame, but upon disconnect it was discovered that the connect fitting had been leaking oxygen into the panel box. It is theorized that the oxgyen leaking into the panel may have been a source of oxidation allowing an overheated device to combust into flame. The combustion stopped, but the risk of a more serious fire was evident given the source of pure oxygen in proximity. The internal components were replaced with spare parts salvaged from another panel as this item is obsolete from the mfr. The panel was placed back in svc. The date of mfr is not known, but the original installation was in about 1973 as bldg 3 was built. There are no model or serial number labels on the panel. It is possible the original labels came off due to age. Matching the panel to the picture in the product brochure the panel is stock number 321-7660-980 for oxygen, "modular line pressure alarm for recessed installation". The internal power supply circuit board is identified with the part number 208-6077-400. Contact with hill-rom revealed the panel is no longer available, but some internal components would still be available as replacement parts. All panels in the hosp have been inspected for proper operation and checked for signs of overheating or oxygen leaks. No overheating has been found and one connector was found leaking a small amount of oxygen. This minor leak was repaired. The long term risk is that others of these panels may experience a similar overheating or failure of aging components so facility has proposed a phase out project to eventually replace the similar age panels throughout.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1023848
• MDR Report Key: 372024
• Date Received: 2002-01-09
• Date of Report: 2002-01-02
• Date of Event: 2001-10-29
• Date Added to Maude: 2002-01-22
• Event Key: 0
• Report Source Code: Voluntary 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: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: OXYGEN ALARM PANEL
• Product Code: BXH
• Date Received: 2002-01-09
• Model Number: *
• Catalog Number: 321-7660-980
• Lot Number: PART #: 208-6077-400
• ID Number: *
• Operator: OTHER
• Device Availability: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 361157
• Manufacturer: OHIO MEDICAL PRODUCTS DIV OF AIRCO, INC.
• Manufacturer Address: 3030 AIRCO DRIVE PO BOX 7550 MADISON WI 53707 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-01-09