MAUDE Adverse Event Report: OSSUR ICELAND COLD RUSH; PACK, HOT OR COLD, WATER CIRCULATING

Model Number B-232000010

Device Problem Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2015

Event Type  malfunction  

Manufacturer Narrative

Anticipating return of device for further evaluation.

Event Description

A nurse was trying to turn on a cold rush cold therapy device and claims the unit created a small spark and a small shock that was mostly startling.No injury occurred.

Event Description

A nurse was trying to turn on a cold rush cold therapy device and claims the unit created a small spark and a small shock that was mostly startling.No injury occurred.

• Brand Name: COLD RUSH
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): OSSUR ICELAND; grjothals 5; reykjavik, 110 ; IC 110
• Manufacturer (Section G): OSSUR ICELAND; grjothals 5; reykjavik, 110 ; IC 110
• Manufacturer Contact: karen montes ; 27051 towne centre drive; foothill ranch, CA 92610 ; 9493823741
• MDR Report Key: 5258076
• MDR Text Key: 32409932
• Report Number: 3003764610-2015-00015
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: B-232000010
• Device Catalogue Number: B-232000010
• Device Lot Number: 503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2005
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other