MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. JETSTREAM; COLD AND HOT TEMPERATURE THERAPY UNIT

Model Number T700

Device Problem Improper Flow or Infusion (2954)

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

Event Date 04/27/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation findings: the lot number of the sample that was returned by the customer was 41370884.This lot number is actually for finished good part number 400c00.Part number 400c00 is the same as the t700 product that was reported on the complaint by the customer.It has a different part number because it is specific for an individual customer.The serial number of the unit is (b)(4) and the batch number is 71509.Finished good part number 400c00 does not contain a cold therapy blanket in its bill of material.However, complaint sample was returned with a temperature therapy blanket.The work order was reviewed and showed no discrepancies that would have contributed to the reported issue.Testing of the complaint sample was performed on the sample "as is".Meaning without detaching or manipulating the blanket in any way other than how it was returned by the customer.The unit was filled with ice and water and allowed to run; the unit worked correctly with water circulating through the unit and blanket.Leaking was not seen from anywhere on the unit, the unit hose connections, or the blanket connections.Therefore, the customer's report was not verified.Root cause: this is undetermined.Complaint sample performed showed no leaking during the use test performed.Corrections: a replacement was issued.Corrective action: no action was taken because the customer's report was not verified during use test on the complaint sample received.Preventive action: no action was taken because the customer's report was not verified during use test on the complaint sample received.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 when filing complaint.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: unit leaked when pad was attached, several people attempting to connect pad.It leaked all over the patient and the bed, we couldn't get the connectors to snap together without leaking, several tried.How was the quality issue was identified? by actual use.How was the product being used? post operative 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.Outcome details: outcome(s) attributed to quality issue: other.Person(s) affected by outcome(s) checked above: none.Known pre-existing condition(s) of person(s) affected: none specified.Was the incident reported to the fda? no.Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: had to change dressing patient bed, etc.

• Brand Name: JETSTREAM
• Type of Device: COLD AND HOT TEMPERATURE THERAPY UNIT
• 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: 5670905
• MDR Text Key: 45650252
• Report Number: 2320762-2016-00004
• 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: 04/28/2016,05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T700
• Device Lot Number: 41370884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2016
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2016
• Date Manufacturer Received: 04/28/2016
• 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