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 2020-02-14 for RADICAL-7 HANDHELD 25052 9500 manufactured by Masimo - 52 Discovery.
[180202975]
Additional manufacturing narrative: the returned device was evaluated. During evaluation the device passed all visual and functional testing. The unit was found to visually and audibly alarm during alarm conditions. The unit was determined to be functioning as designed.
Patient Sequence No: 1, Text Type: N, H10
[180202976]
The customer reported the device sometimes switches off with no reason even if the battery is fully charged. No patient impact or consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011353843-2020-00018 |
| MDR Report Key | 9714867 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-02-14 |
| Date of Report | 2020-01-23 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-01-23 |
| Device Manufacturer Date | 2017-04-12 |
| Date Added to Maude | 2020-02-14 |
| 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 | RADICAL-7 HANDHELD |
| Generic Name | OXIMETER |
| Product Code | DQA |
| Date Received | 2020-02-14 |
| Returned To Mfg | 2020-01-31 |
| Model Number | 25052 |
| Catalog Number | 9500 |
| 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 | 2020-02-14 |