FDA Adverse Event Other Summary report: N

MASIMO CORPORATION

MDR report key: 1349369 · Received March 20, 2009

Report

Report Number: 2031172-2009-00001
Event Type: Other
Date Received: March 20, 2009
Date of Event: February 1, 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

IN THE REPORT SUBMITTED BY THE HOSPITAL, THE CUSTOMER STATES THAT "TREATMENT WAS ADMINISTERED FOR SEVERAL DAYS." INVESTIGATION INTO THE TYPE OF TREATMENT ADMINISTERED REVEALED THE USE OF AQUAPHOR. THE TREATMENT ADMINISTERED DOES NOT QUALIFY AS MEDICAL INTERVENTION PER THE DEFINITIONS LISTED IN 21 CFR PART 803.3. 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. IN CONDUCTING OUR INVESTIGATION, MASIMO WAS UNABLE TO CONFIRM THAT THE DEVICE WAS USED IN ACCORDANCE WITH DFU.

Description of Event or Problem · 1

EVENT AS DESCRIBED BY CUSTOMER VIA MEDWATCH REPORT (B)(4). "PATIENT HAD MASIMO O2 PROBE ON FOOT. WHEN REMOVED TO ROTATE SITE, PATIENT HAD RED MARK/ABRASION/BLISTER ON FOOT. TREATMENT REQUIRED FOR SEVERAL DAYS."

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	2 MO