MAUDE Adverse Event Report: KENTEC MEDICAL, INC AMERITUS HAVE-A-HEART PROBE COVER; TEMPERATURE PROBE COVER

Model Number 175-S

Device Problem Low Readings (2460)

Patient Problem No Information (3190)

Event Date 07/01/2018

Event Type  malfunction  

Event Description

Customer states that on 2 occasions, the thermal probe cover has caused false low skin temperature readings and increased the isolette temperature, thus elevating the patient's internal body temperature.The actual temperature probe is primarily responsible for temperature readings, so it is currently unknown if the probe is not to be at fault for these incidences.At this time, the customer has not provided any product for investigation/analysis, and it is unknown if the product will eventually be returned.At this time, investigation has not commenced, awaiting more information from the customer.This type of complaint on this device is extremely rare.

• Brand Name: AMERITUS HAVE-A-HEART PROBE COVER
• Type of Device: TEMPERATURE PROBE COVER
• Manufacturer (Section D): KENTEC MEDICAL, INC; 17871 fitch; irvine CA 92614
• Manufacturer Contact: keith rooks ; 17871 fitch; irvine, CA 92614 ; 9498630810
• MDR Report Key: 7693923
• MDR Text Key: 114690337
• Report Number: 2080225-2018-00701
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 10817522010175
• UDI-Public: 10817522010175
• Combination Product (y/n): N
• PMA/PMN Number: NOT APPLIC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2020
• Device Model Number: 175-S
• Device Catalogue Number: 175S
• Device Lot Number: 040418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 WK
• Patient Weight: 1