MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC PLASTIPAD; Pack, hot or cold, water circulating

Model Number	82196
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint # (b)(4) received.The device was not returned to the manufacturer for evaluation.Gentherm clinical narrative: 1.If this patient was lying on an or table for 20+ hours the risk for skin breakdown is extraordinarily high, without any cooling blanket under them.2.Contributing factors to tissue injury; immobility, poor nutrition, dehydration, skin condition, perfusion, underlying health conditions, incontinence, friction, shear, obesity.3.Only run the blanketrol at 4c until the patient reaches the desired temperature.It is not necessary to keep the blanketrol at 4c the whole case.After they reach the desired temperature, titrate the temperature up to keep the patient at that level.4.Gentherm recommends checking the patient's skin condition every 20 minutes.
Event or Problem Description
The customer reports that our equipment gets condensation quickly and because of condensed water the patient got bed sore.Additional customer information: the customer used the blanketrol iii in manual mode to cool the patient on and off for 20 to 24 hour and maintain at 4°c , after that the patient got skin injury.

• Brand Name: PLASTIPAD
• Common Device Name: Pack, hot or cold, water circulating
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• Manufacturer (Section G): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• Manufacturer Contact: angie gegner ; 12011 mosteller rd; cincinnati, OH 45241 ; 5133265228
• MDR Report Key: 21547763
• Report Number: 1516825-2025-00002
• Device Sequence Number: 20607722
• Product Code: ILO
• UDI-Device Identifier: 10613031821963
• UDI-Public: 10613031821963
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K101589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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
• Device Model Number: 82196
• Device Catalogue Number: 196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2025
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown