N
Patient 1
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.
MAUDE MDR 6845266
- MDR report key
- 6845266
- Report number
- 3008729547-2017-00010
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-11-30
- Date received
- 2017-09-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 600
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- KRISTOF SOOS
- Address
- MILWAUKEE MILWAUKEE WI US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TRUSAT | OXIMETER, EAR | CRITIKON DE MEXICO S. DE R.L. DE C.V. | DPZ | Y | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-09-06 | 0 | 1. D |
Event Narratives#
D
Patient 1
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.
N
Patient 1
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.