MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-10-22 for INTOXILYZER 5000 manufactured by Mpd, Inc. / Registered Name: Cmi, Inc..
[735248]
This equipment and police are discriminating against my inability to properly use this breath test equipment. My civil rights are being violated, i continue to suffer physical and mental trauma and have lost friends and family. State trooper did not follow required methods or procedures to comply to strict requirements by manufacturer of this equipment see test results and 3-minute time lapse before subject was taken (exhibit 1). Forensic svc technician certified the equipment was accurate although the value expected and value obtained deviated by more than +/-. 3 which failed this accuracy check (exhibit 2). These breath test results have been used against me by the falsified testimonies of this tech and trooper. Horrid discrimination. I did not receive cert. To accuracy of equipment. There was more than one breath test taken but was never produced. Officer claimed i met requirements. Two different police officers sign implied consent form, see exhibit 1 & 2 to one breath test supplied - exhibit 3. Neither of these officers took any given breath test. The officer whom transported me gave me these tests. He was younger looking with light colored - hair. The requirements to compliance were not met.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004163 |
| MDR Report Key | 931835 |
| Date Received | 2007-10-22 |
| Date of Report | 2007-10-03 |
| Date of Event | 2005-09-10 |
| Date Added to Maude | 2007-11-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTOXILYZER |
| Generic Name | ALCOHOL BREATH TEST SYSTEM/MEDICAL CLASS 1 DEVICE |
| Product Code | DJZ |
| Date Received | 2007-10-22 |
| Model Number | 5000 |
| Operator | OTHER |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 922682 |
| Manufacturer | MPD, INC. / REGISTERED NAME: CMI, INC. |
| Manufacturer Address | KY US |
| Brand Name | INTOXILYZER |
| Generic Name | ALCOHOL BREATH TEST SYSTEM/MEDICAL CLASS 1 DEVICE |
| Product Code | DJZ |
| Date Received | 2007-10-22 |
| Model Number | 5000 |
| Operator | OTHER |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 2 |
| Device Event Key | 922683 |
| Manufacturer | MPD, INC. / REGISTERED NAME: CMI, INC. |
| Manufacturer Address | KY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-10-22 |