O.R. SOLUTIONS
Received Feb 29, 2012 · Event occurred Feb 22, 2012
Report 2476084 · MDR key 2476084
Device
Generic name
Warmer Drape
Manufacturer
O.r. SolutionsModel number
ORS-100Catalog number
ORS-100
Lot number
0811003
Product problems
- Hole In Material
- Melted
Patient
42 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A HOLE WAS FOUND IN A STERILE IRRIGATION DRAPE. IT APPEARS TO HAVE MELTED. TESTING OF THREE SEPARATE WARMERS CONFIRMED THE TEMPERATURE WAS STABLE AND WITHIN TOLERANCE.======================MANUFACTURER RESPONSE FOR WARMER DRAPE, O.R. SOLUTIONS (PER SITE REPORTER).======================MANUFACTURER PROVIDED THE RETURN GOODS AUTHORIZATION (RGA) NUMBER FOR PRODUCT RETURN ANALYSIS.======================MANUFACTURER RESPONSE FOR WARMING UNIT, O.R. SOLUTIONS (PER SITE REPORTER).======================MANUFACTURER PROVIDED TESTING GUIDELINES TO TEST THE THREE UNITS THAT THE DRAPE COULD HAVE POSSIBLY BEEN USED. NO TESTING DISCREPANCIES WERE NOTED. ALL UNITS WERE WITHIN TOLERANCE. THE TEMPERATURE WAS 118-122 DEGREES FAHRENHEIT.