FDA Adverse Event Other Summary report: N

MASIMO CORPORATION

MDR report key: 1349367 · Received March 20, 2009

Report

Report Number: 2031172-2009-00003
Event Type: Other
Date Received: March 20, 2009
Date of Event: December 8, 2008
Report Date: March 10, 2009
Manufacturer: MASIMO CORPORATION
Product Code: DQA
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PER THE DIRECTIONS FOR USE (DFU) ACCOMPANIED WITH THE SENSOR MASIMO CLEARLY ALERTS THE END USER OF THE FOLLOWING: THE SITE MUST BE CHECKED AT LEAST EVERY EIGHT HOURS TO ENSURE ADEQUATE ADHESION, CIRCULATION, SKIN INTEGRITY AND CORRECT OPTICAL ALIGNMENT. CIRCULATION DISTAL TO THE SENSOR SITE SHOULD BE CHECKED ROUTINELY. EXERCISE CAUTION WITH POORLY PERFUSED PATIENTS; SKIN EROSION AND/OR PRESSURE NECROSIS MAY OCCUR. DURING LOW PERFUSION, THE SENSOR SITE NEEDS TO BE ASSESSED FREQUENTLY FOR SIGNS OF TISSUE ISCHEMIA, WHICH CAN LEAD TO PRESSURE NECROSIS. MASIMO WAS UNABLE TO OBTAIN OBJECTIVE EVIDENCE THAT THE DEVICE WAS USED IN ACCORDANCE WITH DFU.

Description of Event or Problem · 1

(B)(4). "THE PT HAD A MASIMO SET LNCS PROBE PLACED ON TOE. UPON ASSESSMENT, STAFF REPORTED SKIN BREAKDOWN. ABOUT NINE DAYS LATER, WOUND CARE NURSE REPORTED THAT ON THE UNDERSIDE OF THE LEFT BIG TOE, PT HAD SKIN BREAKDOWN WITH BURN TYPE LESION MEASURING 1.5 X .5CM. STAFF REPORT THAT THE WOUND WAS BLACKENED, NECROTIC AND UNSTAGEABLE. WOUND CARE NURSE REPORTS THAT SKIN IS HEALING AND ESCHAR IS DROPPING."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MASIMO CORPORATION	ADHESIVE INFANT SPO2 SENSOR	DQA	MASIMO CORPORATION	LNCS INFANT	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	2 YR