FDA Adverse Event Malfunction Summary report: N

NIBP CUFFS

MDR report key: 24520830 · Received March 5, 2026

Report

Report Number: 9610816-2026-100447
Event Type: Malfunction
Date Received: March 5, 2026
Date of Event: February 4, 2026
Report Date: March 5, 2026
Manufacturer: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
Product Code: OED
UDI-DI: 20884838114825
PMA / PMN Number: K071885
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SI
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

A PHILIPS PRODUCT INDUSTRIALIZATION ENGINEER (PIE) AND REGULATORY AFFAIRS SPECIALIST (RAS) REVIEWED THE AVAILABLE DATA AND CONFIRMED THAT THE WORD CUFF WAS MISSING FROM THE PRODUCT; THIS AFFECTED THE GRAPHIC PRINTING ON THE CUFF BODY. FOR THIS ONE DEVICE. BASED ON THE RESULTS OF THE ANALYSIS, IT WAS DETERMINED THAT THE PRODUCT HAS MALFUNCTIONED AND THE MOST LIKELY CAUSE OF THE REPORTED PROBLEM WAS A PRINTING ISSUE ON THIS DEVICE. THE ISSUE WAS BEING RESOLVED BY A REVIEW ALL CUFFS' CDLMS (GENTLE LS-200080, EASY LS-200081, COMFORT LS-200078, NEONATAL LS-200079, AND AIR HOSES LS-200082) TO CHECK IF THERE ARE MARKINGS TO BE ADDED TO THE CDLM.

Description of Event or Problem · 0

PHILIPS RECEIVED A COMPLAINT ON AN GENTLE CARE CUFF, SMALL ADULT, 1-TUBE INDICATING THAT THE CENTRAL COE MV (CENTER OF EXCELLENCE MARKET VERIFICATION) PERFORMED A VERIFICATION OF LABELING AND FOUND A LACK OF THE FULL NAME OF THE DEVICE ON THE PRODUCT, THE LABEL WORD "CUFF" MISSING, THE LACK OF LOT INDICATOR AND A LACK OF THE LEGAL MANUFACTURER'S ADDRESS AND INDICATOR. THIS WAS NOTED DURING INSPECTION; NO ADVERSE EVENT OR HARM WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
582495	NIBP CUFFS	ANTIMICROBIAL BLOOD PRESSURE CUFF	OED	PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH	GENTLE CARE CUFF, SMALL ADULT, 1-TUBE		20884838114825

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown