MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-07-06 for RD SET TC-I 4053 manufactured by Masimo - 40 Parker.
[113394776]
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. The masimo clinical specialist noted that the customer was concerned about differences between the masimo and nellcor results but that there was no information that suggests treatment was given or withheld based on the spo2 measurements, and the customer did not claim that masimo technology caused or contributed to adverse consequences for the patient.
Patient Sequence No: 1, Text Type: N, H10
[113394777]
At 5:30 am on (b)(6) 2018 the patient was admitted post cardiac arrest with acute respiratory distress syndrome (ards). Patient was placed on a ventilator, in a prone position, fio2 0. 60, peep +10. The customer reported that the masimo spo2 readings were higher than the blood draw. The customer changed to a nellcor sensor and the spo2 readings were lower. The patient expired the morning of (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031172-2018-00376 |
| MDR Report Key | 7668296 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-07-06 |
| Date of Report | 2018-06-13 |
| Date of Event | 2018-06-11 |
| Date Mfgr Received | 2018-06-13 |
| Date Added to Maude | 2018-07-06 |
| 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 CAREGIVERS |
| 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 | 2018-07-06 |
| Model Number | 4053 |
| Catalog Number | 4053 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Death | 2018-07-06 |