MAUDE Adverse Event Report: COLLINS ELECTRONICS CORP. INTERFACE CABLE, HEWLETT PACKARD 400 SERIES; CONTINUOUS MEASUREMENT THERMOMETER

Model Number	81-1010HP
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "significant fluctuations in temperature." deroyal industries, inc.Requested return of the device but it has yet to be received.A supplier corrective action request (scar) has been issued to the supplier (b)(4).This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report when additional information becomes available.
Event or Problem Description
A user facility reported, "significant fluctuations in temperature.".
Additional Manufacturer Narrative
A user facility reported, "significant fluctuations in temperature." customer provided information that this complaint was entered in error and should be deleted.Customer entered incorrectly and did not mean to file.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: INTERFACE CABLE, HEWLETT PACKARD 400 SERIES
• Common Device Name: CONTINUOUS MEASUREMENT THERMOMETER
• Manufacturer (Section D): COLLINS ELECTRONICS CORP.; 1f., no. 52, lane 137; sec. 2, xinsheng n. road; taipei 104, ; TW
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 23815359
• Report Number: 2320762-2025-00019
• Device Sequence Number: 15943507
• Product Code: FLL
• UDI-Device Identifier: 00749756140249
• UDI-Public: 00749756140249
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K925791
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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
• Operator of Device: Health Professional
• Device Model Number: 81-1010HP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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