NA WEP-4208ARecalls & reported problems
Nihon Kohden Corporation · Telemetry System · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04931921114957), received between Nov 3, 2016 and Feb 3, 2017 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Application Interface Becomes Non-Functional Or Program Exits Abnormally” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Application Interface Becomes Non-Functional Or Program Exits Abnormally1
- Device Displays Incorrect Message1
- Device Inoperable1
- Device Operates Differently Than Expected1
- Device Operational Issue1
- Device Stops Intermittently1
- Radiofrequency Interference (RFI)1
- Wireless Communication Problem1
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2017Radiofrequency Interference (RFI); Device Displays Incorrect Message; Device Operational Issue; Wireless Communication Problem; Radiofrequency Interference (RFI); Device Displays Incorrect Message; Device Operational Issue; Wireless Communication Problem
THE CUSTOMER REPORTED THAT THE WEP TELEMETRY SYSTEM SIGNAL SHOWED A ZIG ZAG WAVEFORM ON MULTIPLE CHANNELS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6301066 ↗MalfunctionJan 27, 2017Application Interface Becomes Non-Functional Or Program Exits Abnormally; Device Inoperable; Application Interface Becomes Non-Functional Or Program Exits Abnormally; Device Inoperable
THE CUSTOMER REPORTED THAT THE TELEMENTRY SYSTEM (WEP) DEVICE WAS BOOTING TO A "SYSTEM DIAGNOSTIC CHECK" SCREEN THAT DISPLAYED A "MAIN BOARD FAILURE" ERROR MESSAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6284949 ↗MalfunctionNov 3, 2016Device Operates Differently Than Expected; Device Stops Intermittently; Device Operates Differently Than Expected
THE CUSTOMER REPORTED THAT THEY EXPERIENCED TELEMETRY SIGNAL NOISE INTERMITTENTLY ON MULTIPLE CHANNELS ON THEIR LOANER TELEMETRY SYSTEM (WEP) DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6077979 ↗
Other MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) devices
- IntelliVue MX40 1.4GHz MX40 1.4 GHz Smart HoppingPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall47 deaths2,541 reports
- NA PU-621RNihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)17 deaths1,666 reports
- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)7 recalls8 deaths1,217 reports
- NA PU-681RANihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)22 deaths1,493 reports
- IntelliVue Multi-Measurement Module X3 IntelliVue X3Philips Medizin Systeme Böblingen GmbH · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall19 deaths1,172 reports
- Patient Information Center IXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)82 deaths941 reports
- Patient Information Center iXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)83 deaths814 reports
- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)5 recalls541 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.