MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-26 for ALCOTEST 7110 MKIII-C manufactured by Draeger Safety Diagnostic.
[16098363]
On (b)(6) 2010, i was arrested for dwi in the township of (b)(6) in the state of (b)(6). I was directed to blow into a draeger alcotest 7110 mkiii-c. The serial number was (b)(4). The device reported a long blowing time that i did not believe that i could produce. My suspicions were confirmed by a pulmonologist, dr (b)(6), m. D. It is my understanding that others defendants have produced longer blowing times inconsistent with normal human function. The device is designed so that it is never calibrated for the pulmonary functions that it reports. The liter volume, blowing time, and pressure and flow sensors are not routinely calibrated. In addition, the mfr has failed to comply with 21 cfr part 820. They failed to submit a 510k. They failed to register their production facilities. They changed their software without fda approval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021926 |
| MDR Report Key | 2232210 |
| Date Received | 2011-08-26 |
| Date of Report | 2011-08-26 |
| Date of Event | 2010-02-05 |
| Date Added to Maude | 2011-09-08 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALCOTEST 7110 MKIII-C |
| Generic Name | NONE |
| Product Code | DJZ |
| Date Received | 2011-08-26 |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRAEGER SAFETY DIAGNOSTIC |
| Manufacturer Address | 3135 QUARRY RD. TELFORD PA 18969 US 18969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-26 |