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 Codes	Bruise/Contusion (1754); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the blood pressure cuff did not deflate, causing harm to the patient's arm.After the patient was awakened and extubated following surgery, it was discovered the patient's arm was swollen from the elbow down with red and black and blue areas.No iv lines were present in the arm at the time.At this time, the cuff was loose enough for staff to put a finger in between the arm and the cuff; however, marks were visible on the arm indicating the cuff was at some point very tight.The on call neurosurgical, orthopedic, and vascular surgery physicians were consulted in the operating room to consult.It remains unknown whether there was any intervention required.No other clinical information or medical intervention was reported; therefore, good faith efforts are being performed.
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: reporting institution phone #: (b)(6).Reporter phone #: (b)(6).
Additional Manufacturer Narrative
A philips field service engineer (fse) went to the customer site, and was unable to duplicate the reported issue, as the cuff deflated as normal during evaluation.The fse asked if there was any permanent damage to the patient's arm and if treatment was required, but this was unknown.The fse confirmed that the device had alarmed for being unable to deflate the cuff.Based on the information available and the testing conducted we were unable to replicate the reported problem.The cause of the reported problem at the time of the incident was unable to be determined.The device was confirmed to be operating per specifications and no failure was identified.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: 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: 21777669
• Report Number: 1218950-2025-000209
• Device Sequence Number: 12969046
• Product Code: OED
• UDI-Device Identifier: 00884838003095
• UDI-Public: (01)00884838003095(24EJ)
• 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?: No
• 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
• Patient Sex: Unknown