MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH M1193A REUSABLE NEONATAL HAND/FOOT SPO2 SENSOR (1.5M)

Model Number	989803205881
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a burn developed on the infant's arm where the spo2 sensor was applied.It was indicated medical attention was sought.The device was in use monitoring a patient at the time of the event.An adverse event involving a patient was reported.
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.Reporting institution phone # (b)(6).
Additional Manufacturer Narrative
A philips quality supervisor (pqs) spoke with the onsite personnel to evaluate the device in question.The pqs was informed by the customer that after one hour, the spo2 sensor was removed, revealing a burn with broken blister, which was 2cm x1cm in sizes.The physician classified the burn as second degree due to depth into the dermis, for which preventive antibiotics were prescribed (cloxacillin 10-day course).Additional treatment was provided by a plastic surgeon, which consisted of urgoclean silver dressing every 3 days, followed by every 7-day dressing.Debridement was also performed with vashe wound cleanser.The burn has since healed with a scar remaining.Testing: philips requested the return of the monitor, adapter cable and sensor set for optimal testing of the temperature on the skin.The sensor involved in event 1 (only) was provided to philips.The testing was performed on (b)(6) 2025.The standard for oximeters iso 80601-2-61 defines that temperatures up to 41°c on sensor interface with the skin are considered safe in regard to potential to cause skin damage.The standard considers a temperature of 35 °c as a conservative maximum limit for the skin temperature with sensor off, which means that the rise of the temperature on the interface after turning the sensor on should be less than 6 °c.The instructions for use specify that the sensor¿s application site should change at maximum every 4 hours and recommends inspecting the application site every 2 to 3 hours.Therefore, a 4-hour period was specified for the test, in conjunction of a maximum current of the sensor, to simulate a worst-case condition.The device involved in the harm (in949) was compared with a new product.A maximum rise in temperature, for both sensors, was found to be 5°c.This indicates that the sensors are functioning as designed and in accordance with the regulations.Onsite visit: the philips distributor performed an onsite visit in november of 2024 to observe the site workflow and handling of the device sensors.The findings are summarized below.The sensors are cleaned with a neutral soap solution.They are not submerged during this process.Following the cleaning process, the sensors are completely dried with alcohol.For patients with chlorine cleaning instructions, a 5% chlorine solution is used per chilean health standards.Sensor placement is changed every 3 hours.Photos were taken of the sensors indicating age.Photos were taken displaying sensor damage involving broken straps.Sensors are placed on the arm or leg since the babies were removing the sensors when placed on the hand or foot.Sensor placement: the sensor was placed on the infant¿s arm.Incorrect placement or using unvalidated or incompatible equipment can result in inaccurate readings, putting patients at risk of improper oxygen monitoring.The instructions for use references this issue.Damage: while there was no damage noted on the sensor involved in this event, the investigation determined that in some cases sensors are placed with damaged straps and the strap is being stretched to secure the sensor.A review of this practice determined that the excessive pressure applied due to location and in conjunction with damaged sensor strap may result in tissue ischemia.Per the device instructions for use, sensors should be inspected for damage and any sensor showing signs of damage or alteration must not be used for further patient monitoring, instead, dispose of it using proper disposal procedures.Ambient temperatures: it should be noted to make frequent checks of application sites when working in environments with elevated ambient temperatures.At elevated ambient temperatures, patient skin could be severely burned after prolonged sensor application at sites that are not well perfused.To prevent this condition, be sure to check the patient application sites frequently.All listed sensors operate without risk of exceeding 41°c on the skin if the initial skin temperature does not exceed 35°c.Based on the information available and the testing conducted, the cause of the reported problem was not confirmed.The patient's burn has healed with a scar remaining.A response letter has been provided to the customer to resolve the issue.If additional information is received the complaint file will be reopened.

• Brand Name: M1193A REUSABLE NEONATAL HAND/FOOT SPO2 SENSOR (1.5M)
• Common Device Name: M1193A REUSABLE NEONATAL HAND/FOOT SPO2 SENSOR (1.5M)
• 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: 20109207
• Report Number: 9610816-2024-00566
• Device Sequence Number: 8475485
• Product Code: DQA
• UDI-Device Identifier: 00884838102705
• UDI-Public: (01)00884838102705
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K030973
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: 989803205881
• Device Catalogue Number: 989803205881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2019
• 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): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown