STD-1000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-02-10 for STD-1000 manufactured by Porter Instrument Company, Inc..

Event Text Entries

[42762] An analgesia gas machine (flowmeter) was returned for repair and was received on 1/9/97. Upon evaluation it was determined that the flowmeter could flow nitrous oxide (n2o) without oxygen (o2). This instrument is designed to deliver mixed o2 and n20 to a dental patient. When o2 flow or pressure is not present, the instrument has a feature which stops the flow of n2o. This feature, therfore, had malfunctioned. The co. Follow-up report of the dentist contact states "when the flowmeter was turned off the 3 liter bag continued to fill. The office never saw the meter flow n2o without o23. " therefore, at no time did a patient receive 100% n2o from this device as a result of this malfunction. Co. Has previously submitted mdrs when the failsafe has malfunctioned. Under the current mdr regulations, co. Has determined that this category of product malfunction does not require submission of an mdr and has filed an exemption with the fda on 11/6/96. The regulatory affairs review group/s determination is based on a review that a malfunction would not be likely to cause or contribute to a death or serious injury if it were to recur. As provided in 21 cfr 803. 16, this report or other information recorded by porter instrument co. , inc. Under 21 cfr part 803, does not necessarily reflect a conclusion by porter that the report or information constitutes an admission that the device, or porter instrument co. , inc. , or its employees, caused or contributed to the event. Porter need not admit and may deny that the report or information constitutes an admission that the device, porter instrument co. , inc. Or employees thereof, caused or contributed to an event. This analgesia gas machine (flowmeter) was originally shipped on 2/13/89. The device history record for this unit shows that it has never been returned for service/repair since its original shipment in 1989. Upon return to co, the flowmeter was evaluated by qc. In this evaluation the unit flowed n2o without o2 could be reproduced during the specific failsafe safety check that is part of the evaluation process.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2518157-1997-00007
• MDR Report Key: 68443
• Report Source: 07
• Date Received: 1997-02-10
• Date of Report: 1997-02-07
• Date Mfgr Received: 1997-01-09
• Device Manufacturer Date: 1989-02-01
• Date Added to Maude: 1997-02-14
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Remedial Action: RP
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STD-1000
• Generic Name: ANALGESIA GAS MACHINE
• Product Code: LWM
• Date Received: 1997-02-10
• Returned To Mfg: 1997-01-09
• Model Number: STD-1000
• Catalog Number: STD-1000
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 68425
• Manufacturer: PORTER INSTRUMENT COMPANY, INC.
• Manufacturer Address: 245 TOWNSHIP LINE ROAD PO BOX 907 HATFIELD PA 194400907 US
• Baseline Brand Name: STANDARD 1000
• Baseline Generic Name: ANALGESIA GAS MACHINE
• Baseline Model No: STD-1000
• Baseline Catalog No: NA
• Baseline ID: NA
• Baseline Device Family: MXR-MIXERS STD-STANDARDS
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K923781
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-02-10