MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-21 for MASIMO SET REUSABLE FOREHEAD SENSOR (TFA) PS-10153D manufactured by Masimo Corporation.
[55240819]
Patient Sequence No: 1, Text Type: N, H10
[55240820]
Male patient w/long cardiac history, non-st-elevated myocardial infarction, hyperglycemia, etc. Icu patient noted to have a possible burn/thermal, swelling, welt under the oxygen-saturation probe and the marks were the same shape as the probe itself. Antibiotic creams were applied. Female patient w/long history irritable bowel syndrome and now septic shock and encephalopathy; icu patient post-laparotomy w/colostomy, pre-sacral drain noted to have a possible ulcer under her new oxygen saturation probe, pressure sore, and area around. Band was not too tight, not restrictive. Applied abx ointment. Left ear "burn" or pressure ulcer noted under oxygen probe on skin when removed. Manufacturer response for forehead and ear oxygen saturation probes, (brand not provided) (per site reporter): mfr rep says they have to be moved every hour.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5966034 |
| MDR Report Key | 5966034 |
| Date Received | 2016-09-21 |
| Date of Report | 2016-09-09 |
| Date of Event | 2016-09-01 |
| Report Date | 2016-09-08 |
| Date Reported to FDA | 2016-09-08 |
| Date Reported to Mfgr | 2016-09-08 |
| Date Added to Maude | 2016-09-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MASIMO SET REUSABLE FOREHEAD SENSOR (TFA) |
| Generic Name | OXIMETER, EAR |
| Product Code | DPZ |
| Date Received | 2016-09-21 |
| Model Number | PS-10153D |
| ID Number | 0299 |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MASIMO CORPORATION |
| Manufacturer Address | 9600 JERONIMO IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-21 |