N
Patient 1
MAUDE MDR 5966034
- MDR report key
- 5966034
- Report number
- 5966034
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-09-01
- Date received
- 2016-09-21
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MASIMO SET REUSABLE FOREHEAD SENSOR (TFA) | OXIMETER, EAR | MASIMO CORPORATION | DPZ | PS-10153D | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-09-21 | 0 | 1. O |
Event Narratives#
D
Patient 1
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.