MAUDE Adverse Event Report: RADIOMETER BASEL AG TOSCA SENSOR 92

Model Number	5621000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient received a skin burn on the earlobe.The hospital confirmed that the skin burn caused a blister.
Additional Manufacturer Narrative
The nurse has ignored the patients symptoms.In a 24 year old, cachectic patient (30kg) and muscle dystrophy already a little pressure to the sensor, e.G.Laying on it, or maybe the pressure from the clip in connection with the heat increases the risk to develop a skin ulceration and severe erythema.In the user manual it says maximum recommended application time 12hour at 42°c sensor temperature.Individual patient conditions must considered when deciding to use maximal side time.In cachectic, dystrophic patients a shorter side time is indicated as in patients with muscle dystrophy, skin exposed to pressure may more sensitive to creating ulcerations.Application to the upper chest might be better in this patient group.The customer has acknowledged that this case was caused by mis-use.

• 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: 8735497
• Report Number: 3002807968-2019-00027
• Device Sequence Number: 1937502
• Product Code: DPZ
• UDI-Device Identifier: 05700693096131
• UDI-Public: (01)05700693096131(10)508131(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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5621000
• Device Catalogue Number: 5621000
• Device Lot Number: 508131
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 07/19/2019
• 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