MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2015-09-08 for TOSCA 500 USA 5201008 manufactured by .
[25505534]
The monitor temperature was noted at 44 degrees celsius. The user manual for the tosca 500 states a recommended temperature of 42 degrees celsius and a maximum temperature of 44 degrees celsius. The customer explained that this monitor was used for sleep studies that can last up to 10 hours, and that the site time was set at 9 hours. However, the user manual for tosca 500 instructs a maximum site time of 4 hours when setting the temperature at 44 degrees celsius. The prolonged site time at the high temperature indicates that the event was caused by a user error.
Patient Sequence No: 1, Text Type: N, H10
[25505535]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[69462601]
In the initial report adverse event was checked but it was not an adverse event but a malfunction due to a use error why no mdr should have been filed. Serious injury should have been left blank in initial report. Initial report: the cover letter states "... For a serious injury involving clinitubes". The case concerns tcm tosca 500 sensor 92, so the correct statement is "... For a serious injury involving tcm tosca 500 sensor 92".
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2015-00021 |
| MDR Report Key | 5067272 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2015-09-08 |
| Date of Report | 2017-03-09 |
| Date of Event | 2015-08-05 |
| Date Mfgr Received | 2017-02-28 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2015-09-10 |
| 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 | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | AUSTRASSE 25 |
| Manufacturer City | BASEL CH 4051 |
| Manufacturer Country | SZ |
| Manufacturer Postal | CH 4051 |
| Manufacturer Phone | 8273349 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOSCA 500 USA |
| Generic Name | TOSCA 500 USA MONITOR |
| Product Code | DPZ |
| Date Received | 2015-09-08 |
| Model Number | 5201008 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-08 |