EMERSON HEATING LAMP 96HB *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-01 for EMERSON HEATING LAMP 96HB * manufactured by Philips Respironics (formerly J.h. Emerson Co.).

Event Text Entries

[3575725] Preemie underwent surgery for repair of gastroschisis. After surgery, it was noted,that infant was hypothermic. Warming measures were initiated which included heating lamp. The infant was placed approximately 2. 5-3 feet away from the heating lamp. After returning from the operating room, erythematous region was noted on the right chest below the clavicle. What was the original intended procedure? Warming measuresdevice #1is this a laboratory device or laboratory test? No
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3220840
• MDR Report Key: 3220840
• Date Received: 2013-07-01
• Date of Report: 2013-06-24
• Date of Event: 2013-06-14
• Report Date: 2013-06-24
• Date Reported to FDA: 2013-07-01
• Date Reported to Mfgr: 2013-07-11
• Date Added to Maude: 2013-07-11
• 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: 3
• Reporter Occupation: RISK MANAGER
• 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 Details

• Brand Name: EMERSON HEATING LAMP
• Generic Name: LAMP, INFRARED, THERAPEUTIC HEATING
• Product Code: ILY
• Date Received: 2013-07-01
• Model Number: 96HB
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 20 YRS.
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PHILIPS RESPIRONICS (FORMERLY J.H. EMERSON CO.)
• Manufacturer Address: 1010 MURRY RIDGE LANE MURRYSVILLE PA 15668 US 15668

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-07-01