MAUDE Adverse Event Report: KAZ USA, INC. BRAUN; THERMOMETER

Model Number IRT-302

Device Problem Low Readings (2460)

Patient Problem No Code Available (3191)

Event Date 04/03/2014

Event Type  Other  

Event Description

A consumer reported that her thermometer had allegedly given an inaccurate reading.The device was reading in the normal range despite their son having a fever.The child was given motrin (orally) and was seen by their physician on the following day.There were no further complications and the pt is doing well now.

Manufacturer Narrative

Using a welch allen black body the irt-3020 was retested.The black body was set to 36.0 degrees centigrade and the irt-3020 was set to cal mode.The temperature of the black body was taken and the reading was 55.7 degrees centigrade.These are failing results.The thermometer will be sent to supplier for root cause analysis.

• Brand Name: BRAUN
• Type of Device: THERMOMETER
• Manufacturer (Section D): KAZ USA, INC.; 250 turnpike road; southborough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike road; southborough, MA 01772 ; 5084907236
• MDR Report Key: 3802979
• MDR Text Key: 4369757
• Report Number: 1314800-2014-00035
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRT-302
• Device Lot Number: 950
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other