MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO70

Model Number	956-608
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of incident estimated.The customer reported that two lots of the product were affected: lot number du50: experiry date is 03feb2027 and manufacture date is 03feb2025.Lot number dx51: experiry date is 31mar2027 and manufacture date is 31mar2025.
Event or Problem Description
Radiometer reference number: (b)(4).According to complaint, the customer reported multiple safepico70 samplers (total of 4 samplers for lot number du50 and a total of 9 samplers for lot number dx51) exhibiting signs of corrosion.

• Brand Name: SAFEPICO70
• Common Device Name: SAFEPICO70
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer Contact: anette gram ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 23593262
• Report Number: 3002807968-2025-00136
• Device Sequence Number: 18710288
• Product Code: JKA
• UDI-Device Identifier: 05700699566089
• UDI-Public: (01)05700699566089(17)270203(10)DU50
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K043143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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
• Operator of Device: Health Professional
• Device Model Number: 956-608
• Device Catalogue Number: 956-608
• Device Lot Number: DU50 & DX51
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown