MAUDE Adverse Event Report: SVS LLC PREMIERPRO; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 6801

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Alteration In Body Temperature (2682)

Event Date 11/29/2017

Event Type  malfunction  

Event Description

Rn took patient's axillary temperature with thermometer.The reading was 98 degrees, however, the patient felt quite hot.Rn inserted a rectal probe to assess into patient to assess his temperature.His temperature was 102.

• Brand Name: PREMIERPRO
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): SVS LLC; 14120 ballantyne corporate pl.; ste. 425; charlotte NC 28277
• MDR Report Key: 7163295
• MDR Text Key: 96324324
• Report Number: 7163295
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 6801
• Other Device ID Number: REORDER #6801-6802-6804-6805.
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR