MAUDE Adverse Event Report: RADIOMETER BASEL AG TOSCA SENSOR 92

Model Number	5621000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date is estimated.
Event or Problem Description
It is reported that an elderly patient received a burn mark on the earlobe from a tc sensor.In the tcm tosca/combim operator's manual (software version 3.00, publication 201504, edition e) it is stated that the recommended maximum application time is 8 hours at a sensor skin interface temperature of 42 degrees celsius.According to the hospital the sensor was applied for 12 hours or more at a temperature of 42 degrees celsius and this is believed to be the cause of the burn.The device was checked, but no problems was found.The sensor and monitor has been sent to radiometer for investigation.
Additional Manufacturer Narrative
The application time on the measurement location was longer than stipulated in the ifu.
Additional Manufacturer Narrative
Corrected data: d4, udi# and h4, device manufacturer date.
Additional Manufacturer Narrative
The legal manufacturer in the initial report was stated as radiometer medical aps, the correct legal manufacturer is however radiometer basel ag.
Additional Manufacturer Narrative
In mdr follow-up report #3 h1 was incorrectly ticked off as 'malfunction'.However, it should have been ticked off as 'serious injury', which has been corrected in this follow-up report #4.

• Brand Name: TOSCA SENSOR 92
• Common Device Name: TOSCA SENSOR 92
• Manufacturer (Section D): RADIOMETER BASEL AG; austrasse 25; basel, CH-40 51; SZ CH-4051
• MDR Report Key: 7867822
• Report Number: 3002807968-2018-00056
• Device Sequence Number: 13972036
• Product Code: DQA
• UDI-Device Identifier: 05700693096131
• UDI-Public: (01)05700693096131(10)711271(240)5621000
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 5621000
• Device Catalogue Number: 5621000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 10/03/2018; 09/11/2018; 06/04/2019; 10/21/2019
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 10/04/2018; 10/08/2018; 06/04/2019; 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other