MAUDE Adverse Event Report: ECOLAB / MICROTEK MEDICAL INC. WARMER, IRRIGATION SOLUTION; FLUID WARMING AND SLUSH DRAPE

Model Number ORS-321

Device Problem Material Puncture/Hole (1504)

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

Event Date 04/02/2019

Event Type  malfunction  

Event Description

It was reported that a hole was observed in the warmer side of drape and it was more than condensation.It was significant amount of fluid.No patient complications have been reported as a result of this event.

• Brand Name: WARMER, IRRIGATION SOLUTION
• Type of Device: FLUID WARMING AND SLUSH DRAPE
• Manufacturer (Section D): ECOLAB / MICROTEK MEDICAL INC.; zona franca no. 2; la romana, ; DR
• 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: 8506057
• MDR Text Key: 145619434
• Report Number: 8043817-2019-40017
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/02/2019

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 Expiration Date: 12/15/2020
• Device Model Number: ORS-321
• Device Lot Number: D183499
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1