ZM-540PA
Received Jun 30, 2026 · Event occurred Jun 8, 2026
Report 8030229-2026-06792 · MDR key 25668723
Device
Generic name
Telemetry Transmitter
Manufacturer
Nihon Kohden CorporationModel number
ZM-540PACatalog number
ZM-540PA
Lot number
NA
Product problems
- Power Problem
- Complete Loss of Power
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ZM TRANSMITTER WOULD NOT STAY POWERED ON. HE STATED THAT WITH NEW BATTERIES, IT WOULD SOMETIMES POWER OFF ON ITS OWN AS IF THERE WAS A BATTERY TERMINAL OR CONNECTION ISSUE. 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.
Description of Event or Problem
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ZM TRANSMITTER WOULD NOT STAY POWERED ON. HE STATED THAT WITH NEW BATTERIES, IT WOULD SOMETIMES POWER OFF ON ITS OWN AS IF THERE WAS A BATTERY TERMINAL OR CONNECTION ISSUE. NO PATIENT HARM WAS REPORTED.