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

Model Number HNICU-02

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 06/29/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint ((b)(4)) was received indicating that a hydrogel probe cover (hnicu-02) was not sticking to the infant, which could cause the probes to monitor temperature inaccurately.No lot number was reported and a sample was not returned for evaluation.Due to the nature of the complaint, a corrective and preventive action investigation has been opened and functional testing is being performed.The investigation is ongoing at this time.A supplemental report will be submitted.

Event Description

The hydrogel covers are not sticky and getting gummy in the giraffe warmers.The babies could get overheated if the temperature is not being monitored accurately.

Manufacturer Narrative

The root cause of the reported issue was unable to be determined.The neonatal probe cover sensors are designed to be less aggressive because the product is applied to neonatal skin.Corrective action: 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 the 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.An internal complaint (b)(4) was received indicating that a neonatal probe cover (hnicu-02) was not adhering to the patient's skin.This resulted in inaccurate temperature readings.The defective sample was not available for return.On hand raw material was checked and the process was reviewed.No change to the process or raw material was observed.As a part of the capa investigation, samples were sent to deroyal engineering for evaluation and pull strength testing.Test results met the acceptance criteria.Preventive action: due to the investigation and root cause determination, a preventive action has not been taken.The investigation is complete.If new and critical information is received, this report will be updated.

Event Description

The hydrogel covers are not sticky and getting gummy in the giraffe warmers.The babies could get overheated if the temperature is not being monitored accurately.

• Brand Name: HYDRO-TEMP PROBE COVER
• 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: 5833063
• MDR Text Key: 52073337
• Report Number: 1034876-2016-00009
• 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
• Remedial Action: Replace
• 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: 07/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HNICU-02
• Device Catalogue Number: HNICU-02
• 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: 06/29/2016
• 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