MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. NEONATAL SENSOR PROBE COVER; WARMER, INFANT RADIANT

Model Number HNICU-02

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation summary 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.A lot number was not reported.The initial report indicated a representative sample was available for evaluation.As of the date of this report, the representative sample was not received.Deroyal has received multiple reports in 2016 regarding issues of adherence in the hnicu product line.Due to this trend being identified, deroyal has initiated a corrective and preventive action investigation (capa (b)(4)).Upon completion of the investigation, this report will be updated.The investigation is ongoing at this time.

Event Description

The probe cover isn't adhering to the infant's skin and keeping the probe in place.Therefore, they are receiving inaccurate readings for body temperature.This is a dangerous issue with newborns as the core body temperature needs to be monitored accurately.The probe has to continually be next to the baby's skin.

Manufacturer Narrative

Root cause: 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 (capa (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.Investigation summary: an internal complaint (call (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.However, a representative sample returned for evaluation.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 probe cover isn't adhering to the infant's skin and keeping the probe in place.Therefore, they are receiving inaccurate readings for body temperature.This is a dangerous issue with newborns as the core body temperature needs to be monitored accurately.The probe has to continually be next to the baby's skin.

• Brand Name: NEONATAL SENSOR PROBE COVER
• Type of Device: WARMER, INFANT RADIANT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 185 richardson way; maynardville TN 38707
• 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: 6122477
• MDR Text Key: 60717843
• Report Number: 1034876-2016-00016
• 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: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HNICU-02
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2016
• 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