MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-04-17 for MXR-2000 manufactured by Porter Instrument Co., Inc..
[21951477]
An analgesia gas machine (flowmeter) was returned for repair and was received on 3/24/97 with a note saying "please repair". This instrument is designed to deliver mixed o2 and n2o to a dental pt. When o2 flow or pressure is not present, the instrument has a feature which stops flow in n2o. This unit was included in 1986 mixer modification program (mmp), a voluntary user notification program conducted by company under guidance of fda. Upon evaluation of unit a condition of nitrous oxide (n2o) flow without oxygen (o2) flowing was produced. Co follow-up report of dentist contact states "they did see n2o without o2 flowing, then shut system off and returned it to co. There were no adverse effects to pt as indicated by doctor. Co has previously submitted mdrs when the failsafe has malfunctioned. Under current mdr regulations, co has determined that this category of product malfunction does not require submission of an mdr and had filed an exemption with fda on 11/6/96.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518157-1997-00006 |
| MDR Report Key | 86274 |
| Report Source | 07 |
| Date Received | 1997-04-17 |
| Date of Report | 1997-04-16 |
| Date Mfgr Received | 1997-03-24 |
| Device Manufacturer Date | 1979-05-01 |
| Date Added to Maude | 1997-04-25 |
| 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 | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MXR-2000 |
| Generic Name | ANALGESIA GAS MACHINE |
| Product Code | LWM |
| Date Received | 1997-04-17 |
| Returned To Mfg | 1997-03-24 |
| Model Number | MXR-2000 |
| Catalog Number | MXR-2000 |
| 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 | 85467 |
| Manufacturer | PORTER INSTRUMENT CO., INC. |
| Manufacturer Address | 245 TOWNSHIP LINE RD. HATFIELD PA 194400907 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-04-17 |