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..
[20195092]
An analgesia gas machine (flowmeter) was returned for repair and was received on 3/13/97 with a note saying "safety blown - will flow n2o with o2 shut down to zero". This instrument is designed to deliver mixed o2 and n2o to a dental patient. When o2 flow or pressure is not present, instrument has a feature which stops flow of n2o. This feature, therefore, had malfunctioned. Upon evaluation condition of nitrous oxide (n2o) flow without oxyhen (o2) could not be reproduced. Co follow-up report of dentist contact states "observation was made during a failsafe check. " 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 has filed an exemption with fda on 11/6/96.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518157-1997-00005 |
| MDR Report Key | 86290 |
| Report Source | 07 |
| Date Received | 1997-04-17 |
| Date of Report | 1997-04-16 |
| Date Mfgr Received | 1997-03-13 |
| Device Manufacturer Date | 1996-02-01 |
| 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 | RP |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MXR-2000 |
| Generic Name | ANALESGIA GAS MACHINE |
| Product Code | LWM |
| Date Received | 1997-04-17 |
| Returned To Mfg | 1997-03-13 |
| 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 | 85482 |
| 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 |