MAUDE Adverse Event Report: ECOLAB / MICROTEK DOMINICANA, S.A DRAPE EQUIPMENT SLUSH MACHINE DISK WARMER; FLUID WARMING & SLUSH DRAPES

Model Number ORS-300

Device Problem Material Puncture/Hole (1504)

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

Event Date 05/20/2019

Event Type  malfunction  

Event Description

It was reported that during a procedure, a hole was observed in the drape.The drape was replaced.No patient complications have been reported as a result of this event.

• Brand Name: DRAPE EQUIPMENT SLUSH MACHINE DISK WARMER
• Type of Device: FLUID WARMING & SLUSH DRAPES
• Manufacturer (Section D): ECOLAB / MICROTEK DOMINICANA, S.A; zona franca no. 2; la romana, ; DR
• Manufacturer Contact: anuli okolo-young ; 1 ecolab place; st paul, MN 55102 ; 6512502237
• MDR Report Key: 8660420
• MDR Text Key: 148414076
• Report Number: 8043817-2018-00020
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2019

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: 01/25/2019
• Device Model Number: ORS-300
• Device Lot Number: D190259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/25/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2019
• Date Device Manufactured: 05/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1