MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-06 for TRUSAT manufactured by Critikon De Mexico S. De R.l. De C.v..
[84995839]
Ge healthcare's investigation is on-going at this time. A follow-up report will be submitted when the investigation is completed. Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[84995840]
Ge healthcare received information from an attorney alleging that while being used in a home environment, the trusat malfunctioned in some way in that it did not alarm when the patient stopped breathing or it indicated the patient had a pulse rate and was breathing when he was not. The patient subsequently expired. Ge healthcare? S investigation is ongoing, to attempt to determine the precise alleged malfunction of the device.
Patient Sequence No: 1, Text Type: D, B5
[96860951]
Ge healthcare's investigation summary: the trusat was evaluated and tested in the presence of gehc, patient and customer (preferred homecare/lifecare solutions) representatives where it was initially noted that the device was providing a fault code for a non-operational sensor. It was also noted that the device still contained historical data which indicated that the trusat alarmed for low spo2 at the of the event (meaning the sensor was clearly operational when the event occurred). Furthermore, the trusat was tested for alarm functionality with a new (operational) sensor and was found to be alarming appropriately. It was observed during testing that the volume was set on it very lowest setting although it cannot be confirmed to what setting the volume was configured during the time of the event. The investigation for this event concluded there was no malfunction of the trusat device. The trusat complies with (b)(4) safety standards for alarms and (b)(4) safety standards with respect to volume settings.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008729547-2017-00010 |
| MDR Report Key | 6845266 |
| Date Received | 2017-09-06 |
| Date of Report | 2017-11-01 |
| Date of Event | 2015-11-30 |
| Date Mfgr Received | 2017-10-27 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2017-09-06 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KRISTOF SOOS |
| Manufacturer Street | MILWAUKEE |
| Manufacturer City | MILWAUKEE WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUSAT |
| Generic Name | OXIMETER, EAR |
| Product Code | DPZ |
| Date Received | 2017-09-06 |
| ID Number | UDI NOT REQUIRED |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRITIKON DE MEXICO S. DE R.L. DE C.V. |
| Manufacturer Address | CALLE VALLE DEL CEDRO 1551 JUAREZ MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-09-06 |