INTELLIVUE MX40 2.4GHZ
Report
- Report Number
- 1218950-2025-000657
- Event Type
- Injury
- Date Received
- November 7, 2025
- Date of Event
- September 3, 2025
- Report Date
- December 20, 2025
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- UDI-DI
- 00884838082243
- PMA / PMN Number
- K113125
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. REPORTING INSTITUTION PHONE # (B)(6).
IT WAS REPORTED THAT THE OPERATOR INVOLVED DEVELOPED A BURN INJURY ON THE HAND FOLLOWING THE SUDDEN HEATING AND RUPTURE OF THE AA BATTERIES. THE INJURY WAS LOCALIZED TO THE SURFACE OF THE RIGHT HAND, CATEGORIZED AS A FIRST-DEGREE TO SUPERFICIAL SECOND-DEGREE BURN. THE AFFECTED AREA WAS LIMITED AND DID NOT RESULT IN ANY FUNCTIONAL IMPAIRMENT WITH SIMPLE FIRST AID BEING ADMINISTERED. NO ADDITIONAL TREATMENT, MEDICATIONS, OR SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO PERMANENT DAMAGE OR RESIDUAL EFFECT NOTED DUE TO THE REPORTED ISSUE. PER THE CUSTOMER, THE DEVICE WAS VISUALLY INSPECTED ON SITE. THEIR VISUAL INSPECTION OF THE BATTERY COMPARTMENT AND ADAPTOR REVEALED NO ANOMALIES. IT WAS INDICATED THAT THE BATTERIES INVOLVED WERE DISCARDED DUE TO ELECTROLYTE SOLUTION HAD LEAKED SO ANY ADDITIONAL TESTING OR VISUAL INSPECTION COULD NOT BE PERFORMED. THE CUSTOMER WAS USING BRAND: VARTA MODEL: INDUSTRIAL PRO, TYPE: ALKALINE AA 1.5 V (SINGLE-USE) BATTERIES PURCHASED THROUGH STANDARD SUPPLY CHANNELS (OPEN-MARKET DISTRIBUTION). A PHILIPS PRODUCT SUPPORT ENGINEER (PS) REVIEWED THE INFORMATION PROVIDED. THE PSE DETERMINED THAT IT APPEARS THAT THERE WAS MOST LIKELY, A SHORT CIRCUIT WHICH WAS LEADING TO THE DAMAGE OF THE BATTERIES. THE PICTURE'S PROVIDED SHOW THAT THE BATTERY ADAPTER TRAY CONTACTS ARE BEND AND DIRTY WHICH INDICATE THE POSSIBILITY OF TOOLS BEING USED TO REMOVE THE BATTERIES AND/OR RESIDUALS FROM DISINFECTANTS THAT COULD ALL LEAD TO A SHORT CIRCUIT. THE MX40 INFORMATION FOR USE (IFU) RELEASE B.06.5X INDICATES THAT USE OF PHILIPS RECHARGEABLE LITHIUM-ION BATTERIES OR 3 DURACELL ALKALINE BATTERIES, SIZE AA, MN1500, 1.5V WHICH PHILIPS HAS TESTED FOR USE WITH THE MX40. THE CUSTOMER WAS NOT USING AN APPROVED BRAND OF BATTERIES. THE INFORMATION FOR USE (IFU) ON PAGE 28 ALSO LISTS CAUTIONS AND RECOMMENDATIONS TO REPLACE THE BATTERY ADAPTER EVERY 12 MONTHS AND HOW TO HANDLE THE BATTERIES. THE CUSTOMER WILL BE INFORMED OF THE FINDINGS AND PROVIDED A COPY OF THE LATEST PHILIPS IFU FOR THE MX40. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.
IT WAS REPORTED DURING A ROUTINE BATTERY REPLACEMENT, THE USER DEVELOPED A BURN INJURY ON THE HAND FOLLOWING THE SUDDEN HEATING AND RUPTURE OF THE AA BATTERIES IN THE TELEMETRY DEVICE. THE INJURY WAS LOCALIZED TO THE SURFACE OF THE RIGHT HAND, CATEGORIZED AS A FIRST-DEGREE TO SUPERFICIAL SECOND-DEGREE BURN. THE AFFECTED AREA WAS LIMITED AND DID NOT RESULT IN ANY FUNCTIONAL IMPAIRMENT WITH SIMPLE FIRST AID BEING ADMINISTERED. NO ADDITIONAL TREATMENT, MEDICATIONS, OR SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO PERMANENT DAMAGE OR RESIDUAL EFFECT NOTED DUE TO THE REPORTED ISSUE. THE BATTERIES WERE DISCARDED AND THE TELEMETRY DEVICE WAS SEQUESTERED AS ELECTROLYTE SOLUTION HAD LEAKED INTO THE BATTERY COMPARTMENT. VISUAL INSPECTION OF THE BATTERY COMPARTMENT AND ADAPTOR REVEALED NO ANOMALIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173309 | INTELLIVUE MX40 2.4GHZ | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | MHX | PHILIPS MEDICAL SYSTEMS | MX40 - 2.4 | 00884838082243 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |