MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L HYDRO-TEMP 13 NEONATAL PROBE, YELLOW, PROBE 13; WARMER, INFANT RADIANT

Model Number	HNICU-38
Medical Device Problem Codes	Failure to Sense (1559); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported on 03/01/2023, that "connector on the end of probe was falling out of the machine either during initial use or after a few hours.Babies temperatures were not monitored allowing opportunity for severe danger of overheating to babies.Plug would also register error sign sometimes when plugged into machine.Do not have samples of actual defective products used.".A sample has been requested but has not yet been returned to deroyal industries.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once additional information becomes available.
Event or Problem Description
Connector on the end of probe was falling out of the machine either during initial use or after a few hours.Babies temperatures were not monitored allowing opportunity for severe danger of overheating to babies.Plug would also register error sign sometimes when plugged into machine.Do not have samples of actual defective products used.
Additional Manufacturer Narrative
A sample has been requested and was returned to deroyal industries on 4/12/2023 to be tested.Deroyal reviewed production logs and it was confirmed no similar issues were reported.Work orders, validations, and failure modes and effects analysis (fmea)'s were also reviewed.A complaint to sales ratio was conducted for the hnicu-38 probes and it was found that (b)(4) were sold in the last two years with 3 complaints in that same time period.This comes to a ratio of (b)(4).Root cause: the returned complaint samples were found to have dimensional variations from the dimensions to the design previously purchased from an outside vendor.The following corrective action has been conducted by deroyal: while this dimensional difference was found to be in specification with the verified and validated design, the hnicu-38 mold is being retooled to closer align with the previously purchased hnicu-38 design.Appropriate verification and validation will be completed following the mold update.An inventory check of 53 cases was made and determined to be consistent.All inventory samples, including the returned samples, that were measured were found to have slightly different dimensions than previously purchased hnicu-38 design.This was noted not to be a production error.The design of the deroyal designed product was verified and validated before switching from the purchased product.As part of the design of this product, if a plug were to pull out and stop monitoring temperature, a mitigation is that the infant monitors are set to alarm both visually and auditorily to warn medical professionals that the probe is no longer monitoring the temperature of the infants.Because the design of this product has been validated and this is the only complaint of its type since bringing the manufactured product to the field, it was determined that this issue is not systemic or due a manufacturing error.To more closely align with market expectations of this product, deroyal is updating the mold to be more closely match with the previously purchased version.The receipt of this complaint did not identify a risk that requires new mitigation as it is already mitigated by the alarm process that occurs if temperature is not being monitored for any reason, including a plug being dislodged.Deroyal will continue to monitor for trends for this issue and this product.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: HYDRO-TEMP 13 NEONATAL PROBE, YELLOW, PROBE 13
• Common Device Name: WARMER, INFANT RADIANT
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L; global park, p.o. box 180-3006; 602 parkway,; la aurora, heredia 146 ; CS 146
• Manufacturer (Section G): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L; global park, p.o. box 180-3006; 602 parkway,; la aurora, heredia 146 ; CS 146
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19931706
• Report Number: 9613793-2023-00004
• Device Sequence Number: 2725061
• Product Code: FMT
• UDI-Device Identifier: 00749756666688
• UDI-Public: 00749756666688
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K200319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HNICU-38
• Device Lot Number: 57890112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown