FDA Adverse Event Injury Summary report: N

FIXATION KIT FOR E5280 AND E5260 SENSORS

MDR report key: 1950568 · Received November 1, 2010

Report

Report Number: 3002807968-2010-00010
Event Type: Injury
Date Received: November 1, 2010
Report Date: October 15, 2010
Manufacturer: RADIOMETER MEDICAL APS
Product Code: LKD
PMA / PMN Number: K043003
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ANETODERMA OF PREMATURITY IS A KNOWN CONSEQUENCE OF USING TRANSCUTANEOUS MONITORING ON NEONATES. PREMATURE NEONATES HAVE EXTREMELY DELICATE AND SENSITIVE SKIN, AND IT IS NOT UNUSUAL THAT PATIENTS THIS YOUNG RECEIVE A BRUISE OR ABRASION TO THE SITE THAT HAD THE ADHESIVE ATTACHED TO IT. THE CUSTOMER REPORTED THESE INCIDENTS AS A GENERAL CONCERN. HE IS AWARE THAT THIS OCCURRENCE IS A WELL-KNOWN CONSEQUENCE OF USING THE TC ELECTRODES ON PRETERM NEONATES WITH SENSITIVE SKIN. THE PRODUCT RISK ANALYSIS FOR TC EQUIPMENT DEALS WITH THIS ISSUE, AND RADIOMETER ACCEPTS THE RESIDUAL RISK. THE ADHESIVE USED ON THE FIXING RINGS ARE SUBJECT TO STRICT CONTROL OF THE FORCE NEEDED TO REMOVE THEM BEING EXACTLY 12.5 N PR 25 MM TAPE. THIS IS THE CORRECT ADHESIVE FORCE IN ORDER TO OBTAIN PROPER FIXATION AND EASY REMOVAL OF THE ELECTRODE. THE PRODUCT RISK ANALYSIS WILL BE UPDATED ACCORDING TO PROCEDURE.

Description of Event or Problem · 1

THE USER INFORMED OUR LOCAL DISTRIBUTOR OF A NUMBER OF INCIDENTS WHERE REMOVAL OF THE FIXATION RINGS AFTER USE HAS CAUSED SKIN LESIONS ON PRETERM NEONATAL PATIENTS. THE CUSTOMER DESCRIBED THE PATIENTS AS 7 DIFFERENT BABIES, GESTATIONAL AGES BETWEEN (B)(6), BIRTH WEIGHT BETWEEN (B)(6).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FIXATION KIT FOR E5280 AND E5260 SENSORS	FIX RINGS FOR TC-MONITOR TCM4/40	LKD	RADIOMETER MEDICAL APS	NA	CK-05

Patients

Seq	Age	Sex	Outcome	Treatment
1	168 DA		Required Intervention