MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-23 for MEDGRAPHICS PULMONARY FUNCTION 1085 manufactured by .
[609900]
During gas chromatograph measurement of study, patient's cell phone rang. Interfered with gas measurement, caused spikes, caused premature end of measurement, and resulted in measurement of 299% of predicted value for study. Test repeated with cell phone turned off, no further complications. Anomaly was reliably reproduced using a nextel brand cell phone -same brand as patient. Another type of cell phone was also checked but did not reproduce this anomaly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5001815 |
| MDR Report Key | 839713 |
| Date Received | 2007-04-16 |
| Date of Report | 2007-04-16 |
| Date of Event | 2007-01-23 |
| Date Added to Maude | 2007-04-24 |
| 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 | RISK MANAGER |
| 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 | MEDGRAPHICS PULMONARY FUNCTION |
| Generic Name | NONE |
| Product Code | BZM |
| Date Received | 2007-04-23 |
| Model Number | 1085 |
| Lot Number | 3001119 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 827289 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-16 |