MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-12-20 for RD SET TC-I 4053-9 4053 manufactured by Masimo - 40 Parker.
[131382605]
The device has been returned to the local facility but has not yet been received at the main office for evaluation. Once the device has been returned and investigated, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[131382606]
The customer reported the sensor is providing inaccurately low readings. No patient impact or consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031172-2018-00581 |
| MDR Report Key | 8187911 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-12-20 |
| Date of Report | 2018-11-25 |
| Date of Event | 2018-11-25 |
| Date Mfgr Received | 2019-01-14 |
| Device Manufacturer Date | 2018-05-09 |
| Date Added to Maude | 2018-12-20 |
| 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 | ERICA KLINE |
| Manufacturer Street | 52 DISCOVERY |
| Manufacturer City | IRVINE CA 926181604 |
| Manufacturer Country | US |
| Manufacturer Postal | 926181604 |
| Manufacturer Phone | 9492977863 |
| 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 SET TC-I |
| Generic Name | OXIMETER |
| Product Code | DPZ |
| Date Received | 2018-12-20 |
| Returned To Mfg | 2018-12-03 |
| Model Number | 4053-9 |
| Catalog Number | 4053 |
| Lot Number | 18E04 |
| 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 - 40 PARKER |
| Manufacturer Address | 40 PARKER IRVINE CA 926181604 US 926181604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-20 |