MAUDE Adverse Event Report: KENTEC MEDICAL, INC AMERITUS TEMPERATURE PROBE

Model Number	232
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Complainant stated that the temperature probe and cover separated from the baby and created a "temperature event".If the probe and cover are separated from the patient, it can cause the temperature sensor to read the lower ambient temperatures, which then in turn, increases the temperature within the incubator, as it believes the patient is too cold.Complainant also stated that he and the clinical staff believe that the adhesive separated from the patient because they were using very high levels of humidity in the incubator, and did not necessarily believe it was the fault of the device.Complainant declined to provide any details regarding the patient status or any medical procedures that may have been a result of the device failure, but only to state that there was no death associated with the incident.There have been no recent complaints for either devices, and no other complaints for the lot numbers associated with these devices.Lot number of the temperature probe, catalog code 232, is p-13879.Lot number of the temperature probe cover, catalog code 120, is 070920.The complainant listed the temperature probe as the suspect device, but it appears that it was the probe cover that was the device that malfunctioned.

• Brand Name: AMERITUS TEMPERATURE PROBE
• Common Device Name: TEMPERATURE PROBE
• Manufacturer (Section D): KENTEC MEDICAL, INC; 17871 fitch; irvine CA 92614
• MDR Report Key: 10755095
• Report Number: 2080225-2020-00001
• Device Sequence Number: 17055207
• Product Code: FMT
• UDI-Device Identifier: 10817522010045
• UDI-Public: 10817522010045
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K960080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

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: 232
• Device Catalogue Number: 232
• Device Lot Number: P-13879
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 3 WK
• Patient Weight: 2