MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-04 for RAD-8 22042 9190 manufactured by Masimo - 40 Parker.
[74512364]
The returned device was evaluated which included functional testing. During this testing the unit was found to visually and audibly alarm during alarm conditions. Internal inspection of the device indicated the battery does not hold the minimum acceptable charge capacity. 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
[74512365]
The customer reported that this device shuts itself off after some time of being powered on. The device is able to engage in monitoring. No consequences or impact to patient were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031172-2017-00542 |
| MDR Report Key | 6546273 |
| Date Received | 2017-05-04 |
| Date of Event | 2017-04-17 |
| Date Mfgr Received | 2017-04-17 |
| Device Manufacturer Date | 2015-07-13 |
| Date Added to Maude | 2017-05-04 |
| 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 | GAIL HAPNER |
| Manufacturer Street | 52 DISCOVERY |
| Manufacturer City | IRVINE CA 926181604 |
| Manufacturer Country | US |
| Manufacturer Postal | 926181604 |
| Manufacturer Phone | 9492977000 |
| Manufacturer G1 | INDUSTRIAL VALLERA DE MEXICALI S.A DE C.V. |
| Manufacturer Street | CALZADA DEL ORO, NO. 2001 PARQUE INDUSTRIAL PALACO |
| Manufacturer City | MEXICALI, BAJA CALIFORNIA 21600 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RAD-8 |
| Generic Name | OXIMETER |
| Product Code | DPZ |
| Date Received | 2017-05-04 |
| Returned To Mfg | 2017-04-20 |
| Model Number | 22042 |
| Catalog Number | 9190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MASIMO - 40 PARKER |
| Manufacturer Address | 40 PARKER IRVINE CA 926181604 US 926181604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-04 |