ZM-531PA
Received Jun 25, 2026 · Event occurred Jun 2, 2026
Report 8030229-2026-06764 · MDR key 25627420
Device
Generic name
Telemetry Transmitter
Manufacturer
Nihon Kohden CorporationModel number
ZM-531PACatalog number
ZM-531PA
Lot number
NA
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE BIOMEDICAL ENGINEER (BME) STATED THAT THE STAFF REPORTED MULTIPLE TIMES THAT THE ZM TRANSMITTER WOULD NOT ALWAYS GIVE CORRECT ECG READINGS. THE DEVICE WAS ALSO CRACKED. 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) STATED THAT THE STAFF REPORTED MULTIPLE TIMES THAT THE ZM TRANSMITTER WOULD NOT ALWAYS GIVE CORRECT ECG READINGS. THE DEVICE WAS ALSO CRACKED. NO PATIENT HARM WAS REPORTED.