MAUDE Adverse Event Report: ECOLAB FLUID WARMING AND SLUSH DRAPE; WARMER DRAPE, IRRIGATION SOLUTION

Model Number ORS-100

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2019

Event Type  malfunction  

Event Description

It was reported that a drape pinhole was observed prior to use.The drape was replaced and no patient complications have been reported as a result of this event.

• Brand Name: FLUID WARMING AND SLUSH DRAPE
• Type of Device: WARMER DRAPE, IRRIGATION SOLUTION
• Manufacturer (Section D): ECOLAB; 1 ecolab place; st paul MN 55102
• Manufacturer (Section G): ECOLAB; 1 ecolab place; st paul MN 55102
• Manufacturer Contact: anuli okolo-young ; 1 ecolab place; st paul, MN 55102 ; 6512502237
• MDR Report Key: 8663230
• MDR Text Key: 146816694
• Report Number: 8043817-2019-40022
• Device Sequence Number: 1
• Product Code: LHC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORS-100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1