MAUDE Adverse Event Report: CINCINNATI SUB-ZERO CT-99 (COLD THERAPY PAD); PACK, HOT OR COLD, WATER CIRCULATING

Model Number 50137

Device Problems Nonstandard Device (1420); Material Rupture (1546)

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

Event Date 10/30/2014

Event Type  malfunction  

Event Description

The ct-99 is intended to provide a patient with local cold therapy by circulating chilled water through a pad that has been positioned on the patient.This incident refers to a fresh bilateral knee replacement that had both pads rupture on the patient's wound bandages.Hosp does not expose fresh incisions for the first 24 hours.Exposing the incision when replacing bandages or leaving the bandages moist may potentially cause post operation infection.No post operation infection has been reported at this time.

Manufacturer Narrative

• Brand Name: CT-99 (COLD THERAPY PAD)
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): CINCINNATI SUB-ZERO; 12011 mosteller rd.; cincinnati OH 45241
• Manufacturer Contact: christina miracle ; 12011 mosteller rd.; cincinnati, OH 45241
• MDR Report Key: 4404697
• MDR Text Key: 5126382
• Report Number: 1516825-2014-00003
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50137
• Device Lot Number: 13390
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/04/2014
• Date Manufacturer Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2013
• 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
• Patient Outcome(s): Other