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

Model Number 401C3

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

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 in that leaking was seen.The leaking occurred due to broken unit connectors, not broken blanket connectors.A corporate level corrective action preventive action (capa) was initiated and assigned to deroyal engineering to lead investigation.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 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.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

Detailed description of quality issue: product was used by both nursing staff and patients.Blankets leaked onto the patient soaking the dressings.How was the quality issue was identified? by actual use.How was the product being used? cold.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.

• Brand Name: DEROYAL
• Type of Device: HOT OR 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: 6242772
• MDR Text Key: 64595307
• Report Number: 2320762-2016-00029
• 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: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 401C3
• Device Lot Number: 42622449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 01/11/2017
• 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
• Patient Outcome(s): Other