MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; HOT/COLD WATER CIRCULATING UNIT

Model Number T735NS

Device Problem Noise, Audible (3273)

Patient Problem Headache (1880)

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation findings: the call/complaint was received indicating that a failure has occurred with the temperature therapy product.A sample was returned for evaluation.The unit was tested and the reported issue was confirmed.The unit appeared to run louder than normal.The cause of the patient's headache was unable to be determined due to unknown patient sensitivity.Corporate corrective action preventive action (capa), a corporate level corrective action preventive action (capa) was initiated and assigned to deroyal engineering to lead the investigation.Root cause: the true root cause of the reported issue is undetermined at this point of the investigation process.The root cause/s of functional failures will be identified within the referenced capa.The cause of the patient's headache was unable to be determined due to unknown patient sensitivity.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

When did quality issue occur? during use.Who was using or operating the product when the quality issue occurred? health professional.Was a medical procedure involved? no.Detailed description of quality issue: note says "so loud gave patient headache".How was the quality issue was identified? by actual use.How was the product being used? cold therapy post operatively on the rehab floor.Was it the initial use of the product? yes.

• Brand Name: DEROYAL
• Type of Device: HOT/COLD WATER CIRCULATING UNIT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 hwy 33 south; new tazewell TN 37825
• 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: 6197936
• MDR Text Key: 63202005
• Report Number: 2320762-2016-00027
• 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: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T735NS
• Device Lot Number: 42954380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other