Welch Allyn, Inc. 901137 (REF SCSYS-IED-SDFCX)Recalls & reported problems
Welch Allyn, Inc. · Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; Italian language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and no display monitors; Custom number of hard wired patient monitoring slots and telemetry channels; Redundant server (RAID1 +0) storage for up to 1,200 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia, · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00732094323290), received between Dec 31, 2020 and Dec 31, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “No Audible Alarm” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- No Audible Alarm1
Patient problems
- Arrhythmia1
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 31, 2020No Audible Alarm; No Audible Alarm
THE CUSTOMER REPORTED THAT A PATIENT MONITORED WITH AN S4 TELEMETRY SUFFERED AN ARRHYTHMIA AND THAT THE SURVEYOR CENTRAL DID NOT ALARM THE EVENT FAILING TO WARN THE NURSES WITH THE SOUND. THERE WAS NO REPORT OF PATIENT INJURY OR DEATH RECEIVED. THE ARRHYTHMIA WAS STOPPED BY THE PATIENT ICD SHOCK AND THE PATIENT ITSELF CALLED THE NURSES TO TELL THEM ABOUT IT. THE PATIENT HAD NO FURTHER HEALTH ISSUES AFTER THE EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: Arrhythmia; No Patient Involvement
MAUDE report 11100308 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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