ZM-530PA
Received May 21, 2026 · Event occurred Apr 30, 2026
Report 8030229-2026-06635 · MDR key 25247441
Device
Generic name
Telemetry Transmitter
Manufacturer
Nihon Kohden CorporationModel number
ZM-530PACatalog number
ZM-530PA
Lot number
NA
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT THE ZM TRANSMITTER WAS PRODUCING INCORRECT ECG HEART RATE (HR) READINGS. IT DISPLAYED TACHYCARDIA WHEN THE PATIENT HAD A NORMAL HR., HE TESTED THE DEVICE ON A SIMULATOR AND GOT THE SAME RESULTS. NO PATIENT HARM WAS REPORTED.
Additional Manufacturer Narrative
THE BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT THE ZM TRANSMITTER WAS PRODUCING INCORRECT ECG HEART RATE (HR) READINGS. IT DISPLAYED TACHYCARDIA WHEN THE PATIENT HAD A NORMAL HR. HE TESTED THE DEVICE ON A SIMULATOR AND GOT THE SAME RESULTS. NO PATIENT HARM WAS REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.