MAUDE Adverse Event Report: OWENS & MINOR DISTRIBUTION, INC. MEDICHOICE; PACK, HOT OR COLD, WATER CIRCULATING

Model Number HTP020

Device Problems Fluid/Blood Leak (1250); Defective Device (2588)

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

Event Date 06/12/2019

Event Type  malfunction  

Event Description

Water circulating pad leaking around the tubing at base of where the tubing exits the pad, resulting in patient and bed being soaked with water.Pad was removed from service.Left a voicemail with manufacturer rep.Reported the event, also informed that defective product was saved.Defective product picked up and one new sample not used.

• Brand Name: MEDICHOICE
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): OWENS & MINOR DISTRIBUTION, INC.; 9120 lockwood blvd; mechanicsville VA 23116
• MDR Report Key: 8868786
• MDR Text Key: 153525063
• Report Number: 8868786
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HTP020
• Device Lot Number: A1300119D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1