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

Model Number 38581

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2021

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 is providing lower than expected readings.No patient impact or consequences were reported.

Event Description

The customer reported the device is providing lower than expected readings.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacturing narrative: other, other text: the returned device was evaluated.The unit powered on and off using battery power.The device is unable to obtain any measurement and watchdog alarm "lo" is shown on the display when trying to obtain measurement.Since the unit is unable to obtain measurements, temperature accuracy testing couldn't be performed.The watchdog alarm "lo" was narrowed down to the contamination damages on the lens of the emitter.Attempted to clean the lens but the issue persisted.A service history record review reveals that this unit was in the field for over eight (8) months with no previous reported issues related to this reported event.

• 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: 11378837
• MDR Text Key: 233555460
• Report Number: 3011353843-2021-00046
• 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: 02/03/2021

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: 02/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 05/10/2021
• Supplement Dates FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1