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 Co., Inc..
[46686]
An analgesia gas machine (flowmeter) was returned for repair and was received on 1/23/97 with a note saying "estimate of repair-overhaul". Upon eval 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 pt. When o2 flow or pressure is not present, the instrument has a feature which stops the flow of n2o. This feature, therefore, had malfunctioned. The co's follow-up report of the dentist contact states "no pts were exposed to 100% n2o". Therefore, at no time did a pt receive 100% n2o from this device as a result of this malfunction. Co has previously submitted mdr's 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518157-1997-00002 |
| MDR Report Key | 68499 |
| Report Source | 07 |
| Date Received | 1997-02-10 |
| Date of Report | 1997-02-07 |
| Date Mfgr Received | 1997-01-23 |
| Device Manufacturer Date | 1984-08-01 |
| Date Added to Maude | 1997-02-18 |
| 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 |
| Reporter Occupation | DENTIST |
| 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 |
| Brand Name | STD-1000 |
| Generic Name | ANALGESIA GAS MACHINE |
| Product Code | LWM |
| Date Received | 1997-02-10 |
| Returned To Mfg | 1997-01-23 |
| 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 | 68480 |
| Manufacturer | PORTER INSTRUMENT CO., INC. |
| Manufacturer Address | 245 TOWNSHIP LINE RD. P.O. 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-02-10 |