MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH MR PATIENT CARE INFANT SPO2 GRIPS (20)

Model Number	INFANT SPO2 GRIPS (20)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
It was reported the patient developed a wound under the spo2 sensor.The patient was brought for mri scan and an mri safe spo2 sensor was placed on the right foot.After the mri, which lasted approximately 30-35 minutes, a wound on the top of the foot was noted.It was unknown whether the wound was a burn.It was bleeding slightly when the sensor was removed.The foot was swollen, red, and tender to touch.The wound was covered with a mepilex dressing, which is a foam dressing with silver contained within it.The parents were made aware of the wound and they voiced no concerns.
Additional Manufacturer Narrative
Multiple good faith efforts attempts have been conducted to gather more information but have been unsuccessful.Based on the information available and the testing conducted, the cause of the reported problem is unknown.The reported problem was not confirmed.We are unable to confirm the final disposition of the device, because the customer did not respond to requests for additional information.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: MR PATIENT CARE INFANT SPO2 GRIPS (20)
• Common Device Name: MR PATIENT CARE INFANT SPO2 GRIPS (20)
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 22627948
• Report Number: 9610816-2025-000675
• Device Sequence Number: 12993713
• Product Code: MWI
• UDI-Device Identifier: 10884838117904
• UDI-Public: (01)10884838117904(10)E100512091
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K090785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: INFANT SPO2 GRIPS (20)
• Device Catalogue Number: 989803166571
• Device Lot Number: E100512091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown