PHILLIP/BIOTEL HEART MONITOR
Received Apr 3, 2025 · Event occurred Jan 3, 2024
Report MW5168567 · MDR key 21763707
Device
Generic name
Electrocardiograph, Ambulatory (without Analysis).
Manufacturer
Philips North America Llc.Product problems
- Break
- Improper or Incorrect Procedure or Method
- Component Missing
- Patient Device Interaction Problem
Patient
50 YR · Female
- Arrhythmia
- Arthritis
- Erythema
- Inflammation
- Muscle Weakness/Atrophy
- Neuropathy
- Pain
- Tachycardia
- Burning Sensation
- Twitching
- Electric Shock
- Unspecified Eye / Vision Problem
- Cramp(s) /Muscle Spasm(s)
- Swelling/ Edema
- Complex regional pain syndrome
- Arrhythmia
- Arthritis
- Erythema
- Inflammation
- Muscle Weakness/Atrophy
- Neuropathy
- Pain
- Tachycardia
- Burning Sensation
- Twitching
- Electric Shock
- Unspecified Eye / Vision Problem
- Cramp(s) /Muscle Spasm(s)
- Swelling/ Edema
- Complex regional pain syndrome
Narrative
Description of Event or Problem
MEDICAL ASSISTANT OF (B)(6) DIDN'T ADHERE TO THE MANUFACTURE MANUAL FOR THE DEVICE. MEDICAL ASSISTANT DIDN'T PUT DEVICE IN REQUIRED AREA BY MANUFACTURE SPECIFICATION AND SHE DIDN'T FOLLOW THE WARNING PRECAUTIONS ON PAGE 21 AND ON PAGE 22 IT SAYS IF PRODUCT IS DAMAGED IT CAN BURN AND SEND AN ELECTRIC DISCHARGE FROM DEVICE. SHE DIDN'T ADHERE TO MANUAL WHEN IT SAID THAT DEVICE HAS TO BE 3 FINGER WIDTHS FROM COLLARBONE TO PLACE DEVICE AND SHE PLACED DEVICE AT COLLARBONE. I DON'T BELIEVE SHE FOLLOWED THE CLEANING AREA PROCEDURE ACCORDING TO MANUAL AND DON'T REMEMBER HER SHARING ABOUT WARNING OF THE DEVICE TO ME. I HAVE DOCUMENTATION THAT PROVIDE THAT DEVICE WAS NOT MANUFACTURED CORRECTLY, IT IS MISSING ELECTRIC LEADS AND PARTS ARE EXPOSED (DEFECTIVE MONITOR). DEVICE WAS PUT ON (B)(6) 2024. I GOT ELECTROCUTED AND BURNED BY A PHILLIPS/BIOTEL HEART HOLTER MONITOR WHICH DAMAGED MY LEFT SIDE AND DIAGNOSIS WITH NEUROPATHY, BRACHIAL NEURITIS, CAUSALGIA OF LEFT UPPER LIMB, SPONDYLOSIS WITH RADICULOPATHY, CERVICAL REGION, OCCIPITAL NEURALGIA, WEAKNESS, ABNORMAL REFLEX, 2 CHEST LESIONS WHERE BURN OCCURRED (NUMBNESS, WEAKNESS, TWITCHING OF FINGERS, BURNING SENSATIONS, PINS AND NEEDLE FEELINGS, LUMPS LYMPH, SPASMS, SWELLING ON LEFT SIDE) AND SENDS ELECTRIC SHOCKS, THROBBING TO BACK OF MY HEAD AND BURNING SENSATION IN HEAD. I HAVE IMPAIRMENTS ON LEFT LEG AND LEFT TOES AND ALSO INCLUDES LEFT AND RIGHT EYES IMPAIRMENT. HEART MONITOR TEST SHOWING HIGH BEATS PER MINUTE 124 AND IMPAIRMENT (PAGE 6 SINUS TACHYCARDIA, SUPRAVENTRICULAR TACHYCARDIA, VENTRICULAR BIGEMINY, VENTRICULAR TRIGEMINY) OLD AND NEW ECHO CARDIO SHOWING A NEW IMPAIRMENT (DIASTOLIC DYSFUNCTION), WHEN ECHO TEST WAS NORMAL LAST YEAR. REDNESS IN DIFFERENT PARTS OF BODY. MY HEART BPM CONTINUES TO GO ABOVE 100 AT REST.