MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. HYDRO-TEMP COVER WITH FOAM; WARMER, INFANT RADIANT

Model Number HNICU-01

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

Root cause: due to the lack of a returned sample or lot information, the root cause could not be determined.Corrective action: due to the investigation and root cause information, a corrective action has not been taken.Investigation summary: an internal complaint (b)(4) was received for a neonatal temperature probe cover (finished good hnicu-01) that wasn't sticking, causing inaccuracies in the temperature reading.A sample was not returned and a lot number was not reported.The roll stock for the gel adhesive (raw material 13620) was inspected at the manufacturing facility.No issue was identified.From 2014 to present, a total of (b)(4) have been sold.In 2016, a total of six reports have been received regarding adherence issues with neonatal temperature probe covers.Due to this trend being identified, a corrective and preventive action (b)(4) has been opened.Upon completion of the capa investigation, this complaint investigation will be reviewed for updates.Preventive action: due to the investigation and root cause determination, a preventive action has not been taken.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

The cover wasn't sticking very well and lifted a little, causing the temperature to be inaccurate.Thus, the warmer would kick on when it wasn't necessary.

Manufacturer Narrative

Deroyal opened a corrective and preventive action investigation (b)(4) to examine a trend of complaints related to the neonatal probe cover line.This was due to reported adherence issues with the neonatal probe covers.This capa was closed with a root cause determination that the probe covers are designed to be less aggressive because the product is applied to neonatal skin.This root cause does not change the results of the complaint investigation for mdr 1034876-2016-00014 (internal complaint call (b)(4)).

Event Description

The cover wasn't sticking very well and lifted a little, causing the temperature to be inaccurate.Thus, the warmer would kick on when it wasn't necessary.

• Brand Name: HYDRO-TEMP COVER WITH FOAM
• Type of Device: WARMER, INFANT RADIANT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 185 richardson way; maynardville TN 37807
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 185 richardson way; maynardville TN 37807
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 5890053
• MDR Text Key: 52624728
• Report Number: 1034876-2016-00014
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HNICU-01
• Device Catalogue Number: HNICU-01
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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