ZM-540PA
Received Jun 15, 2026 · Event occurred May 26, 2026
Report 8030229-2026-06738 · MDR key 25505346
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 THIS TRANSMITTER FAILED THE AIR LEAK TEST AND SHUTS DOWN. DISCOVERED DURING TESTING AND NOT IN PATIENT USE. 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 THIS TRANSMITTER FAILED THE AIR LEAK TEST AND SHUTS DOWN. DISCOVERED DURING TESTING AND NOT IN PATIENT USE. NO PATIENT HARM WAS REPORTED.