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 2020-03-14 for RD SEDLINE SENSOR 4248 manufactured by Masimo - 52 Discovery.
[183472495]
The returned device was evaluated. External visual inspection found no physical damage. The pads on the electrodes were removed and fiber remains from pads and dried gel deposits were observed on the electrodes. Continuity testing across the surface of the electrodes found an open circuit across all of the electrodes. The gel and fiber residue was removed and good continuity was found across the electrodes. Continuity testing was performed between the electrodes surface and the connector and found an open circuit between the ct electrodes and the connector. The sensor was returned used. Functional testing could not be performed since the sensor is intended for single-patient use; the integrity of the sensor (gel; contacts; etc) is broken once it is removed from patient use. The sedline sensor couldn? T be detected due to an open circuit between ct electrode and the tip of the connector.
Patient Sequence No: 1, Text Type: N, H10
[183472496]
The customer reported the patient state index (psi) was not in the expected range. No patient impact or consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011353843-2020-00034 |
| MDR Report Key | 9832858 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-14 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-07-10 |
| 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 |
| 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 | RD SEDLINE SENSOR |
| Generic Name | MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) |
| Product Code | MWI |
| Date Received | 2020-03-14 |
| Returned To Mfg | 2020-03-06 |
| Model Number | 4248 |
| Catalog Number | 4248 |
| Lot Number | 19GDA |
| 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 |