MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY TIR-1 THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 38581

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

Attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.

Event Description

The customer reported the device had inaccurate readings.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacturing narrative: the returned device was evaluated.External visual inspection found no damage.The device was able to power on using lab stock batteries, obtain measurements and pair with a known good root.Measurements obtained during the initial water bath test were outside the device specification.Microscopic analysis found contamination on the ir sensor lens.This was cleaned and the water bath temperature test was redone.The obtained measurement values remained outside the device specification.A service history record review showed the device has been in the field for over six (6) months with no previously reported issues related to this complaint.

Event Description

The customer reported the device had inaccurate readings.No patient impact or consequences were reported.

• Brand Name: TIR-1 THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11282357
• MDR Text Key: 230464010
• Report Number: 3011353843-2021-00019
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• PMA/PMN Number: K131771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 38581
• Device Catalogue Number: 4301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 03/02/2021
• Supplement Dates FDA Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1