NIBP CUFFS
Report
- Report Number
- 9610816-2025-000722
- Event Type
- Injury
- Date Received
- August 8, 2025
- Date of Event
- July 3, 2025
- Report Date
- March 3, 2026
- Manufacturer
- PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
- Product Code
- OED
- UDI-DI
- 00884838082588
- PMA / PMN Number
- K071885
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
CORRECTIONS WERE MADE TO THE FOLLOWING FIELDS: CFN/FEI# IS UPDATED TO 9610816. D3 MANUFACTURING SITE: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH. G1 CONTACT OFFICE: (B)(6). G1 CONTACT OFFICE ENTITY: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH.
THE PRODUCT IS CHANGED TO THE M4555B EASY CARE CUFF 1 HOSE, ADULT (1). SINCE THE CAUSE OF THE ISSUE WAS OCCLUSION OF THE CUFF TUBE, THIS PRODUCT MORE ACCURATELY REFLECTS THE ISSUE. PLEASE SEE THE CHANGES TO THE FOLLOWING FIELDS: 510K IS UPDATED TO K071885. CFN/FEI# IS UPDATED TO 1218950. D1 BRAND NAME: NIBP CUFFS. D2A COMMON DEVICE NAME: ANTIMICROBIAL BLOOD PRESSURE CUFF. D2B PROCODE: OED. D3 MANUFACTURING SITE: PHILIPS MEDICAL SYSTEMS. D4 CATALOG ITEM IDENTIFIER: M4555B. D4 SERIAL NUMBER: NO INFORMATION. D4 UDI: NO INFORMATION. G1 CONTACT OFFICE: (B)(6). G1 CONTACT OFFICE ENTITY PHILIPS MEDICAL SYSTEMS. H4 MANUFACTURE DATE: NO INFORMATION.
A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND COLLECTED THE LOGS, DEVICE REPORTS, AND PICTURES OF THE NON-INVASIVE BLOOD PRESSURE (NIBP) HOSE, CONNECTOR, AND CUFF USED IN THE OPERATING ROOM (OR). 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.
A PHILIPS TECHNICAL CONSULTANT WENT ON-SITE. THE CLINICAL AUDIT LOG, DEVICE CONFIGURATION INFORMATION, DEVICE REPORTS AND PHOTOS WERE GATHERED FOR EVALUATION. THE DETAILS OF YOUR FACILITY ACTIVITIES TO REPRODUCE THE ISSUE WERE OBTAINED AND THE ISSUE WAS ESCALATED AT PHILIPS. THE FACILITY MEDICAL ENGINEERING STAFF ISOLATED THE CUFF FOR TESTING AND REVIEWED THE DEVICE LOGS FROM THIS OPERATING ROOM CASE. THE STAFF DID NOT IDENTIFY ANY ALARMS THAT WOULD HAVE ALERTED STAFF TO THIS SITUATION. ADDITIONALLY, MEDICAL ENGINEERING CONDUCTED TESTS ON THE BP CUFF AND X3 IN QUESTION AND FOUND NO ERROR WITH REGULAR USE. DURING THE MEETING CONDUCTED ON SEPTEMBER 25, 2025, THE PHILIPS PRODUCT SUPPORT ENGINEER (PSE) WAS ABLE TO SUMMARIZE THE INVESTIGATION INTO THE ISSUE. HAVING REGISTERED A VALID MEASUREMENT, THE X3¿S NBP PUMP¿S VALVES ARE OPENED RELEASING THE NBP CUFF PRESSURE. HAVING SUCCESSFULLY OPENED THE VALVES, THE X3 DEVICE IS NOT DESIGNED TO DETECT AN OBSTRUCTION IN THE NBP HOSE LINE DURING THIS PROCESS OF CUFF DEFLATION. THE RATIONALE FOR THIS PRODUCT DESIGN IS BASED IN THE IEC MEDICAL DEVICE STANDARD 60601-2-30. THE STANDARD ACKNOWLEDGES LINE KINKING TO BE AN UNLIKELY PHENOMENON REFERENCED IN SECTION 3.7. *3.7 UNLIKELY PHENOMENA. ADDITION: AA) KINKING OF THE HOSES, INTERRUPTING THE FLOW OF AIR COMPLETELY, IS UNLIKELY TO OCCUR. ADDITIONALLY, SECTION 22.4.2 EXPLICITLY EXCLUDES LINE KINKING FROM THE DEFINITION OF A SINGLE FAULT CONDITION. *22.4.2 IN ANY MODE OF OPERATION, INCLUDING ANY SINGLE FAULT CONDITION AS DESCRIBED IN 3.6 OF THIS PARTICULAR STANDARD, THE CUFF SHALL NOT BE INFLATED ABOVE 15 MM HG FOR MORE THAN 180 S FOR EQUIPMENT SPECIFIED FOR USE ON ADULT PATIENTS, AND SHALL NOT BE INFLATED ABOVE 5 MM HG FOR MORE THAN 90 S FOR EQUIPMENT SPECIFIED FOR USE ON NEONATAL PATIENTS, SEE FIGURE 104. COMPLIANCE IS CHECKED BY INTRODUCING ANY SINGLE FAULT CONDITION AS DESCRIBED IN 3.6 OF THIS PARTICULAR STANDARD AND BY MEASURING THE TIME FOR WHICH THE CUFF REMAINS INFLATED, BEGINNING THE TIMING MEASUREMENT AS SOON AS THE CUFF PRESSURE EXCEEDS EITHER 15 MM HG OR 5 MM HG, AS APPROPRIATE. NOTE THE MAINTENANCE OF PRESSURE, DUE ONLY TO THE OBSTRUCTION OF HOSE(S) BY KINKING, IS EXCLUDED FROM THIS REQUIREMENT. AS THE CUFF IS PERFORMING AS DESIGNED, THE CUSTOMER INDICATED THAT THE ISSUE WOULD BE ADDRESSED THROUGH WORKFLOW. THE CUSTOMER WILL ENSURE THE NBP CUFF HOSE IS NOT KINKED DURING SURGICAL PROCEDURES WHERE THE PATIENT'S ARMS ARE TUCKED. THE CUSTOMER WILL TAKE FREQUENT NBP MEASUREMENTS TO ENSURE THE NBP CUFF INFLATES AND DEFLATES WITHOUT ISSUE. A RESPONSE LETTER IS BEING PROVIDED TO THE CUSTOMER TO ADDRESS THE ISSUE.
IT WAS REPORTED DURING A PROCEDURE IN THE OPERATING ROOM, THE BLOOD PRESSURE CUFF REMAINED INFLATED, OCCLUDING THE BLOOD FLOW TO THE PATIENT'S ARM. THE BLOOD PRESSURE CUFF WAS USED TO OBTAIN INITIAL MEASUREMENTS DURING THE FIRST TWO HOURS OF THE CASE. THE PATIENT BECAME HYPOTENSIVE, SO THE OR STAFF CHECKED UNDER THE DRAPES AND DISCOVERED THE BLOOD PRESSURE CUFF WAS NOT DEFLATING ON THE RIGHT ARM. THE ENTIRE ARM WAS SWOLLEN WITH THE RIGHT-HAND APPEARING PURPLE WITH A PURPURIC RASH. THE STAFF INDICATED THE CUFF TUBING WAS NOT KINKED OR OCCLUDED. WHEN THE ISSUE WAS IDENTIFIED, THE BLOOD PRESSURE CUFF WAS REMOVED AND REPLACED, THOUGH THE CUFF WAS NOT ACTUALLY USED. THE USERS THEN MONITORED BLOOD PRESSURE VIA THE ARTERIAL LINE FOR THE REMAINDER OF THE CASE. THE PATIENT'S ARM AND HAND IMPROVED OVER TIME BUT THERE WAS NO ADDITIONAL INFORMATION PROVIDED. IT REMAINS UNKNOWN IF ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO TREAT THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29980 | NIBP CUFFS | ANTIMICROBIAL BLOOD PRESSURE CUFF | OED | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH | EASY CARE CUFF, 1 HOSE, ADULT (1) | 00884838082588 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |