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

Model Number HNICU-01

Device Problems Failure To Adhere Or Bond (1031); Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460)

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

Event Date 02/02/2017

Event Type  malfunction  

Manufacturer Narrative

The root cause is unable to be determined at this time.The returned samples were evaluated and the reported issue could not be confirmed.Due to the root cause, a corrective action has not been taken.Investigation summary: an internal complaint (call (b)(4)) was received reporting that a neonatal probe cover (hnicu-01) was in use with a deroyal temperature probe when a temperature inaccuracy occurred.Additional information received indicated that the probe cover was not adequately sticking to the skin.The end user returned 30 samples.Fifteen of these samples were evaluated and the gel was found to adhere to the skin.The reported issue was unable to be confirmed.The work order was reviewed for the reported lot number (43210323), and it was determined that sub-assembly part 1005 (lots 42519601 and 42955382) was converted for finished good hnicu-01.No discrepancies were identified.Sales were reviewed for the 2015-present time period and (b)(4) cases/(b)(4) each were sold.For the same time period, a trend of similar complaints has been identified for the neonatal probe cover line.Due to the ongoing issue of reported adherence issues with the neonatal probe covers, a corrective and preventive action investigation has been opened.This is capa (b)(4).Upon completion of this capa, the complaint investigation will be reviewed for potential updates.Preventive action: due to the root cause, a preventive action has not been taken.This report has not been filed within the 30 days required by regulation.The report was not filed for review by regulatory affairs upon initial receipt of this complaint in accordance with internal complaint handling procedure.This is due to an isolated error by quality assurance and retraining according to procedure requirements has been scheduled with necessary employees.The quality assurance group manager has reviewed all complaints for the last 3 months to ensure all necessary complaints have been flagged for review by regulatory affairs.The investigation is complete at this time.This report will be updated upon completion of the capa.

Event Description

A deroyal hydrogel with foam cover for a neonatal skin temperature probe was applied to an auxiliary area.The deroyal probe was reading that the patient was cold.However, a giraffe probe read that the baby was hot.The deroyal cover was removed and replaced with a new one that yielded the same reading.The lot has been pulled and no further probe covers have been used.

Manufacturer Narrative

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.This root cause does not change the results of the complaint investigation for mdr 1034876-2017-00001 (internal complaint call (b)(4)).

Event Description

A deroyal hydrogel with foam cover for a neonatal skin temperature probe was applied to an auxiliary area.The deroyal probe was reading that the patient was cold.However, a giraffe probe read that the baby was hot.The deroyal cover was removed and replaced with a new one that yielded the same reading.The lot has been pulled and no further probe covers have been used.

• 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: 6413692
• MDR Text Key: 70345128
• Report Number: 1034876-2017-00001
• 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: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HNICU-01
• Device Lot Number: 43210323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2017
• 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