MAUDE Adverse Event Report: WHITEHALL MFG. / DIV. OF ACORN ENGINEERING CO. DICKSON; PARAFFIN BATH

Model Number PB-104

Device Problem Overheating of Device (1437)

Patient Problem No Information (3190)

Event Date 01/01/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in the report was returned to our facility for evaluation.During the evaluation, it was confirmed that the device exceeded our highest temperature range of 140 to 150°f by an additional 50°f.The device malfunction appears to have been caused by a faulty operating thermostat.Our original manufacturing test records indicate that the device operated normally at the time.No other malfunction was identified.

Event Description

Customer states that the device malfunctioned and was making the paraffin wax get too hot.This could potentially lead to a patient getting burned.

• Brand Name: DICKSON
• Type of Device: PARAFFIN BATH
• Manufacturer (Section D): WHITEHALL MFG. / DIV. OF ACORN ENGINEERING CO.; 15125 proctor ave.; city of industry 91746
• Manufacturer (Section G): FABRICACION Y MANUFACTURAS DE MEXICO S.A.DE C.V.; calle maquiladoras no. 1387-1; cuidad industrial; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: jose munoz ; 15125 proctor ave.; city of industry, CA 91746 ; 8007827706
• MDR Report Key: 6882427
• MDR Text Key: 87497821
• Report Number: 1000323249-2017-00001
• Device Sequence Number: 1
• Product Code: IMC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physical Therapist
• Device Model Number: PB-104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2015
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1