MAUDE Adverse Event Report: SECURITAS HEALTHCARE SECURITAS HEALTHCARE; BED PAD 74030

Model Number	74030
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Very little information was provided in the mdr, sh reached out to the fda for more colour but no additional info could be provided.After some analysis securitas healthcare can say that if the pad melting is caused by a sustained over current event, the m210 unit would likely be destroyed in the process.The pull-up resistance network inside of the m210 would absorb the vast majority of the energy and catastrophically fail.Since this was not reported,sh is skeptical of this failure stemming from a connection with the m210.(sh also doesn't believe that the melting could result from brief spike in current.For plastic to melt, sustained power needs to be applied to the material.) if the failure is electrical in nature, then a possible alternative is that the pad was accidentally connected to another device.Sh is not sure what device would cause this since this type of cable is not often used for power delivery.Since there are no additional details with this complaint, there is no way to know if this actually occurred.Please also note that if this case is filed late, it is due to connectivity with esg nextgen.Securitas has reached out to the mdr helpdesk for assistance, and will file this case asap.
Event or Problem Description
The disposable bed sensor pad for stanley alarm melted through plastic and adhered to waffle mattress.There was no harm to the patient.The electrical outlets were examined and there were no issues identified.The vendor was contacted.

• Brand Name: SECURITAS HEALTHCARE
• Common Device Name: BED PAD 74030
• Manufacturer (Section D): SECURITAS HEALTHCARE; 4600 vine street; lincoln NE 68506
• Manufacturer (Section G): SECURITAS HEALTHCARE; 4600 vine street; lincoln NE 68503
• Manufacturer Contact: garth jack ; lincoln, NE 68503 ; 4027429335
• MDR Report Key: 22309558
• Report Number: 1929691-2025-00002
• Device Sequence Number: 18162996
• Product Code: KMI
• UDI-Device Identifier: 00840948102523
• UDI-Public: 00840948102523
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 74030
• Device Catalogue Number: 74030
• Device Lot Number: NONE GIVEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/23/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 YR
• Patient Sex: Male
• Patient Weight: 163 KG
• Patient Ethnicity: Hispanic
• Patient Race: White