MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH ANTIMICROBIAL CUFF, 1 HOSE, ADULT (1)

Model Number	M4555B
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
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.Box e: (b)(6).
Event or Problem Description
It was reported the blood pressure cuff did not deflate, causing harm to the patient's arm.After a long operation with the patient in the supine position, it was observed the patient's right arm was dark red with black and blue areas and their fingers were swollen.The patient complained of pain in their arm upon waking.After removing the draping, the blood pressure cuff was loose but marks on the arm indicated the cuff may have been applying significant pressure during surgery.The skin on the upper arm where the cuff was placed appeared light red and shiny; however, below the cuff at approximately the elbow crease, the skin was dark red with black and blue areas.It was assumed by the user the cuff had inflated and did not deflate properly due to a kinked hose, causing pressure to be applied to the patient's arm for several hours.
Additional Manufacturer Narrative
A philips field service engineer (fse) went to the customer site.The fse was not able to determine the cause of the kinked hose.The fse asked if there was any permanent damage to the patient's arm and if treatment was required, but this was unknown.Based on the information available and the testing conducted, the cause of the reported problem was a kinked blood pressure cuff hose.The reported problem was confirmed, however, the cause of the kink was not determined.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.The reported patient harm is addressed in 1218950-2025-000210.

• Brand Name: ANTIMICROBIAL CUFF, 1 HOSE, ADULT (1)
• Common Device Name: ANTIMICROBIAL CUFF, 1 HOSE, ADULT (1)
• 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: 21773140
• Report Number: 1218950-2025-000210
• Device Sequence Number: 15503966
• Product Code: OED
• UDI-Device Identifier: 00884838003095
• UDI-Public: (01)00884838003095
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K071885
• 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): 04/24/2025

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: M4555B
• Device Catalogue Number: M4555B
• Device Lot Number: 24EJ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• 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: Other
• Patient Sex: Unknown