MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-14 for RAD-5 PULSE OXIMETER 22330 9196 manufactured by Masimo - 52 Discovery.
[183472340]
Additional manufacturing narrative: other, other text: the returned device was evaluated. Visual inspection upon receiving revealed no external damage or defects. During start up all of the led digits did not light up. The device was able to obtain readings. Internal inspection showed contamination damage on the system circuit board which prevented some of the led digits from lighting up. Additional contamination damage was observed on the tech board and the speaker. A service history record review reveals that this unit was in the field for over ten (10) years with no previous reported issues related to this reported event.
Patient Sequence No: 1, Text Type: N, H10
[183472341]
The customer reported the device has segments on the upper display which do not illuminate. No patient impact or consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011353843-2020-00037 |
| MDR Report Key | 9832851 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-14 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2009-08-25 |
| Date Added to Maude | 2020-03-14 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | RAD-5 PULSE OXIMETER |
| Generic Name | OXIMETER |
| Product Code | DQA |
| Date Received | 2020-03-14 |
| Returned To Mfg | 2020-03-02 |
| Model Number | 22330 |
| Catalog Number | 9196 |
| 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 | 2020-03-14 |