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

Model Number HNICU-01

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Date 06/30/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint (b)(4) was received indicating that a hydrogel probe cover (hnicu-01) was not sticking to the infant, which cause the probe to become exposed to air and affected temperature readings.The initial reporter indicated a sample was available for evaluation.However, the sample has not been received as of july 29, 2016, and a lot number was not reported in the initial complaint.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

Covers are not sticking for very long.They would have to replace the cover after 10-15 minutes.Also, the cover would lift off or "tent" as the customer described.It would cause the measuring probe to become exposed to air, and thus, the temperature reading would be inaccurate.This would result in the babies being too cold or too warm.According to the reporting customer, one baby became so warm it was almost sepsis.They are having to check the babies very regularly to check temperature and check if the cover is still sticking.

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 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.Investigation summary: an internal complaint (call 37631) was received indicating that a neonatal probe cover ((b)(4)) was not adhering to the patient's skin.This resulted in inaccurate temperature readings.The initial reporter indicated a sample was available for evaluation.However, the sample was not received and a lot number was not reported in the initial complaint.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

Covers are not sticking for very long.They would have to replace the cover after 10-15 minutes.Also, the cover would lift off or "tent" as the customer described.It would cause the measuring probe to become exposed to air, and thus, the temperature reading would be inaccurate.This would result in the babies being too cold or too warm.According to the reporting customer, one baby became so warm it was almost sepsis.They are having to check the babies very regularly to check temperature and check if the cover is still sticking.

• Brand Name: HYDRO-TEMP PROBE 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: 5833066
• MDR Text Key: 50738233
• Report Number: 1034876-2016-00010
• 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: Other
• 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-01
• Device Catalogue Number: HNICU-01
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2016
• 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