SMART MONITOR SMART MONITOR 2PS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-27 for SMART MONITOR SMART MONITOR 2PS * manufactured by Respironics Inc..

Event Text Entries

[3911466] Infant on smart monitor at bedside. Required 2 pulse ox probes; one for cardiac monitor and one for oxygen monitor. During shift report at 2300, top of left foot had reddened/blister area from pulse ox. When moving smart monitor pulse ox from right hand at 2330 assessment; small reddened area noted on palm; staff believe this is a possible burn area from pulse ox. No blister. Removed pulse ox and replaced with new one. Apn notified. No additional medical treatment required.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3417273
• MDR Report Key: 3417273
• Date Received: 2013-09-27
• Date of Report: 2013-09-27
• Date of Event: 2013-09-24
• Report Date: 2013-09-27
• Date Reported to FDA: 2013-09-27
• Date Reported to Mfgr: 2013-10-17
• Date Added to Maude: 2013-10-17
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: SMART MONITOR
• Generic Name: MONITOR, OXYGEN, CUTANEOUS, FOR USES OTHER THAN FOR INFANT N
• Product Code: LPP
• Date Received: 2013-09-27
• Model Number: SMART MONITOR 2PS
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 4 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RESPIRONICS INC.
• Manufacturer Address: 1010 MURRY RIDGE LANE MURRYSVILLE PA 15668 US 15668

Device Sequence Number: 2

• Brand Name: MASIMO SET
• Generic Name: OXIMETER
• Product Code: DQA
• Date Received: 2013-09-27
• Model Number: LNOP NEO-L
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 1 DA
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MASIMO CORP.
• Manufacturer Address: 9600 JERONIMO IRVINE CA 92618 US 92618

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-09-27