MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-01-24 for ROOT 25926 9515 manufactured by Masimo - 52 Discovery.
[179249663]
Additional manufacturing narrative: other, other text: the returned device was evaluated. External visual inspection showed no damaged. The unit was unable to power on using either ac or battery power. Internal inspection isolated the failure to a component on the isolation board. Inspection of the component indicated it had shorted. Following the installation of a known-good isolation board the unit was fully functional. A service history record review reveals that this unit was in the field for over one (1) year with no previous reported issues related to this reported event.
Patient Sequence No: 1, Text Type: N, H10
[179249664]
The customer reported the root wasn't able to be turned on after powering off during surgery. No patient impact or consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011353843-2020-00001 |
| MDR Report Key | 9630133 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-01-24 |
| Date of Report | 2019-12-30 |
| Date of Event | 2019-12-27 |
| Date Mfgr Received | 2019-12-30 |
| Device Manufacturer Date | 2018-12-27 |
| Date Added to Maude | 2020-01-24 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEFAN LISSMANN |
| Manufacturer Street | 52 DISCOVERY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9492977168 |
| Manufacturer G1 | MASIMO - MEXICALI |
| Manufacturer Street | INDUSTRIAL VALLERA DE MEXICALI CALZADA DEL ORO, NO.2001 |
| Manufacturer City | MEXICALI, BAJA CALIFORNIA 21600 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21600 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROOT |
| Generic Name | MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) |
| Product Code | MWI |
| Date Received | 2020-01-24 |
| Returned To Mfg | 2020-01-08 |
| Model Number | 25926 |
| Catalog Number | 9515 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MASIMO - 52 DISCOVERY |
| Manufacturer Address | 52 DISCOVERY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-24 |