MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-11-15 for MXR-2000 manufactured by Porter Instrument Company, Inc..
[28935]
While on a field service call for another product, a dealer received a complaint from a dentist saying "the % of n2o was off". Analgesia gas machine (flowmeter) was returned for repair and was received on 10/9/96. Upon eval it was determined that the flowmeter could flow n2o without o2. This instrument is designed to deliver mixed o2 and n2o to a dental pt. When o2 flow or pressure is not present, instrument has a feature which stops the flow of n2o. This feature, therefore, had malfunctioned. Co follow-up report of the dentist contact states "there was no pt involved, he had noticed that the % were way off and then used the meter as a standard meter (by the ballfloats)". 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 regulations, co has exemption with the fda on 11/6/96.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518157-1996-00004 |
| MDR Report Key | 50458 |
| Report Source | 05 |
| Date Received | 1996-11-15 |
| Date of Report | 1996-11-14 |
| Date Mfgr Received | 1996-10-09 |
| Device Manufacturer Date | 1995-12-01 |
| Date Added to Maude | 1996-11-22 |
| 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 | MXR-2000 |
| Generic Name | ANALGESIA GAS MACHINE |
| Product Code | LWM |
| Date Received | 1996-11-15 |
| Returned To Mfg | 1996-10-09 |
| 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 | 51164 |
| Manufacturer | PORTER INSTRUMENT COMPANY, INC. |
| Manufacturer Address | 245 TOWNSHIP LINE RD PO BOX 907 HATFIELD PA 194400907 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-11-15 |