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 2020-01-30 for RAD-97 W/CAPNOGRAPHY 26040 9799 manufactured by Masimo - 52 Discovery.
[179252047]
Additional manufacuring narrative: attempts have been made to obtain the product. The product has not been returned to masimo to allow an analysis to be performed. If the product is returned for evaluation or new information is obtained, a follow up report will be submitted. Other text : device not returned.
Patient Sequence No: 1, Text Type: N, H10
[179252048]
The customer reported the rad-97 "failed during operation giving an alert 'module error'. This renders the co2 function inoperable and requires the unit be sent back to masimo for evaluation. " no patient impact or consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011353843-2020-00009 |
| MDR Report Key | 9650276 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-09 |
| Date of Event | 2019-12-05 |
| Date Mfgr Received | 2020-01-09 |
| Date Added to Maude | 2020-01-30 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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/CAPNOGRAPHY |
| Generic Name | OXIMETER |
| Product Code | MWI |
| Date Received | 2020-01-30 |
| Model Number | 26040 |
| Catalog Number | 9799 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-30 |