MAUDE Adverse Event Report: TONIC STUDIOS ASIA LIMITED DEROYAL; HOT/COLD TEMPERATURE PUMP UNIT

Model Number T700

Device Problem Electronic Property Issue (2928)

Patient Problems Electric Shock (2554); No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation findings a call/complaint was received indicating that a failure (unit was shocking the end user) occurred with the temperature therapy product.- review of the work order showed no discrepancies that would have contributed to the reported issue.- the sample was returned for evaluation and testing.Prior to testing, the unit and power cord were inspected for breaks or anything that would have contributed to shocking the patient and none were seen.The unit was tested by filling it with ice and water, connecting a cold therapy blanket to the unit hoses, plugging in the power cord and allowing the unit to run.This was performed several times.- the first time the unit ran for approximately three minutes before the light on unit turned solid red and unit stopped running.The solid red light normally indicates that the temperature is above 120°f/48.9°c.Since this unit was set up for cold therapy, the solid red light should not have come on.- the second time the unit was run for at least 40 min and unit ran as normal.- during testing setup and actual testing, the unit did not shock the testers.The reported issue for the unit shocking the end user is not confirmed.Since january 2015 there have been (b)(4) t700 units sold with no other reports of a failure of this type (unit shocking the end user).(b)(4).Although the reported shock issue was unconfirmed, the call will be covered under the corporate capa due to the light turning red after running for three minutes.This is a corporate level corrective action preventive action (capa) that was initiated and assigned to deroyal engineering to investigate.This unit is produced by a contract manufacturer to deroyal's specifications.A supplier notification letter (snl) has been sent to ensure supplier awareness of the frequency of post market issue.Root cause: the root cause of the reported shock issue is undetermined and the investigation team was unable to reproduce this occurrence.The root cause/s of the solid red light coming on will be identified within the referenced capa.Corrections: replacements or credits have been issued to the customer.Corrective action: to be determined as part of corporate level capa that is currently in process.Preventive action: to be determined as part of corporate level capa that is currently in process.No further information is available at this time.We will provide follow up report if additional information becomes available.

Event Description

Date of occurrence: (b)(6) 2016.When did quality issue occur? during use.Who was using or operating the product when the quality issue occurred? patient/end consumer.Detailed description of quality issue: unit returned to customer with patient complaint that it was shocking end user.Customer reported that there was no patient injury.Unit was replaced by customer.How was the quality issue was identified? by actual use.How was the product being used? post surgery cold therapy.Was it the initial use of the product? no.Was the product modified from the original condition supplied by deroyal? no.Was the product connected to or used in conjunction with other devices or equipment? no.Known pre-existing condition(s) of person(s) affected: none specified.Was the incident reported to the fda? no.

• Brand Name: DEROYAL
• Type of Device: HOT/COLD TEMPERATURE PUMP UNIT
• Manufacturer (Section D): TONIC STUDIOS ASIA LIMITED; 49-59 queens road east; wanchai; hong kong, ; CH
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 hwy 33 south; new tazewell TN 37825
• Manufacturer Contact: elizabeth reed ; 200 debusk ln; powell 37849 ; 8653621256
• MDR Report Key: 6218323
• MDR Text Key: 63728905
• Report Number: 2320762-2016-00028
• 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
• Type of Report: Initial
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: T700
• Device Lot Number: 43493132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1