MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-21 for RAD-97 W/NIBP 26245 9797 manufactured by Masimo - 52 Discovery.
[180583461]
Additional manufacturing narrative: the product has been returned to the local facility but has not yet been received at the main office for evaluation. Once returned and investigated, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[180583462]
The customer reported the device shows wrong measurements. No patient impact or consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011353843-2020-00028 |
| MDR Report Key | 9742331 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-19 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-03-14 |
| Date Added to Maude | 2020-02-21 |
| 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-97 W/NIBP |
| Generic Name | OXIMETER |
| Product Code | MWI |
| Date Received | 2020-02-21 |
| Returned To Mfg | 2020-02-06 |
| Model Number | 26245 |
| Catalog Number | 9797 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2020-02-21 |