MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; COLD THEMPERATURE THERAPY UNIT AND BLANKET

Model Number 400C00

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 07/26/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation findings: the lot number reported by the customer is for a different part number (400c00) than the one reported (t736ns).The 400c00 is just the cold therapy unit alone and does not come with a cold therapy blanket.Part number t736ns is the same cold therapy unit and it does come with a therapy blanket.A review of the work order showed no discrepancies that would have contributed to the reported issue.The complaint sample was received.A 5036 blanket was returned with the unit (400c00).The blanket was not attached to the unit hoses.Visual inspection of the blanket showed that the o-rings were on both of the blanket "legs".This is noted because missing o-rings could be a possible leak source.It also showed that the lot number label was worn off the blanket.Therefore, the blanket lot number is unknown and its work order cannot be reviewed.Testing was performed by putting ice and water inside it, attaching the blanket to the unit hoses, turning the unit on and allowing it to run.The unit ran for 22 minutes and worked correctly and leaking was not seen from anywhere on the unit or blanket.He customer's report could not be verified.Root cause: undetermined due to leaking was not seen when testing was performed.Corrections: a replacement was issued.Corrective action: no corrective action taken due to the customer's report was not verified.Preventive action: no preventative action taken due to the customer's report was not verified.No further information is available at this time.We will provide follow up report if additional information becomes available.

Event Description

The quality issue details and the outcome details section copied below are responses given by the initial reporter to the deroyal complaint questionnaire.*** quality issue details *** 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? health professional.Was a medical procedure involved? no.Name of medical procedure: not applicable.Did the quality issue cause a delay in the medical procedure? not applicable.Detailed description of quality issue: upon inspection patient prior to transport to unit from pacu found patient leg soaked and padding on cpm machine wet as well.How was the quality issue was identified? by actual use.How was the product being used? cold therapy on patient knee.Was it the initial use of the product? yes.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.*** outcome details *** outcome(s) attributed to quality issue: other.Person(s) affected by outcome(s) checked above: facility employee.Known pre-existing condition(s) of person(s) affected: n/a.Was the incident reported to the fda? no.Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: changed patient over to new pump and changed patient dressings.

• Brand Name: DEROYAL
• Type of Device: COLD THEMPERATURE THERAPY UNIT AND BLANKET
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 hwy 33 south; new tazewell TN 37825
• Manufacturer Contact: marian vargas ; 200 debusk ln; powell 37849 ; 8653621013
• MDR Report Key: 5904261
• MDR Text Key: 53048296
• Report Number: 2320762-2016-00011
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/27/2016,08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 400C00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/26/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2016
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other