Ascom Mobile Monitoring Gateway (MMG)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 17350088670009), received between Aug 20, 2018 and Aug 9, 2019 — classified as 3 deaths.

The most frequently reported specific device problem is “Device Alarm System” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K111215); they may or may not involve this specific model.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathAug 9, 2019Device Alarm System; Device Alarm System

  ON 11 JULY, 2019 AT 11:01 AM, ASCOM VP OF PROFESSIONAL SERVICES, (B)(6), RECEIVED AN EMAIL FROM (B)(4). (B)(4) IS OUR DISTRIBUTION PARTNER FOR ASCOM PRODUCT CALLED MMG. MS. (B)(4) RECEIVED AN EMAIL AT 10:19 AM THIS SAME MORNING FROM (B)(6), DIRECTOR OF PATIENT CARE SERVICES AT (B)(6) MEDICAL CENTER ((B)(6)). IN THAT EMAIL MS. (B)(6) STATED THE FOLLOWING: "WE HAD ANOTHER SENTINEL EVENT THAT WE ARE INVESTIGATING. THE ASCOM SYSTEM WAS SENDING THE ALARMS TO THE DAY SHIFT STAFF INSTEAD OF THE NIGHT SHIFT STAFF. THE ASSIGNMENTS FOR NIGHT SHIFT WERE IN RESPONDER APPROPRIATELY AND AT 1900. (B)(6) REACHED OUT TO SOMEONE TWO DAYS AGO AND WE STILL HAVE NOT HEARD ANYTHING BACK. ONCE AGAIN THIS IS UNACCEPTABLE. WE HAD A PATIENT PASS AWAY DUE TO THE SYSTEM ALARMING TO THE WRONG ASSIGNMENTS. AT THIS POINT THEY ARE MOST LIKELY GOING TO MAKE US STOP USING THE ASCOM PORTION OF THIS SYSTEM. I NEED A RESPONSE AT OUR 1100 MEETING. ALSO, THE PATIENT ACCOUNT (B)(6), (B)(6) 2019 FROM 1830-2045 I NEED EVERYTHING FROM (B)(4) AND ASCOM SIDE FROM THIS PATIENT. I HAVE A MEETING TOMORROW MORNING WITH THE CEO ABOUT THIS SITUATION AND I NEED THIS INFORMATION ASAP." ON 11 JULY, 2019 ASCOM'S TECHNICAL ASSISTANCE CE

  Patient problems: Death

  MAUDE report 8878938 ↗
• DeathJul 11, 2019Device Alarm System; Alarm Not Visible; Device Alarm System; Alarm Not Visible

  ON 12 JUNE 2019 AT 2:42 PM AN EMAIL COMMUNICATION WAS RECEIVED FROM (B)(6), A PROJECT IMPLEMENTATION REPRESENTATIVE FROM OUR SALES AND DISTRIBUTION PARTNER, (B)(4) THIS EMAIL WAS SENT TO MEMBERS OF THE ASCOM CLINICAL APPLICATIONS SPECIALIST TEAM, AND IMPLEMENTATION TEAM. HER EMAIL INDICATED THAT THE "ASCOM PHONE ALARM RELAY" <SIC> WAS NOT WORKING ON UNITS 6 AND 7, AND THAT THE CUSTOMER HAD EXPERIENCED A SENTINEL EVENT THAT MORNING, WITH THE NURSES REPORTING THAT THE ALARMS WERE NOT RELAYED TO THE PHONE. (B)(6) INDICATED THAT THEY HAD ATTEMPTED TO ANALYZE EVENTS USING THE ACTIVITY VIEWER ON THE ASCOM SYSTEM BUT THE DATA WAS NOT CLEAR TO THEM AND ASKED IF ASCOM COULD PROVIDE A REPORT FOR THE ALARMS RECEIVED AND SENT TO PHONES FOR ROOM 454 FROM 8:00 AM THROUGH 8:30 AM CENTRAL STANDARD TIME. SHE REQUESTED "...A REPORT FOR ALL THE ALARMS RECEIVED AND THEN SENT TO PHONES FOR ROOM 454 FROM 8:00AM THROUGH 8:30AM CST..." AND TO INCLUDE "THE PHONE NUMBER IT WAS SENT TO, AND THE COURSE OF ESCALATION INCLUDING EACH DESTINATION PHONE." ON (B)(6) 2019 AT 2:50 PM AN EMAIL COMMUNICATION WAS RECEIVED FROM (B)(6), A MEMBER OF THE (B)(4) COMPLAINT HANDLING UNIT (CHU). THIS EMAIL WAS SENT TO THE SAME

  Patient problems: Bradycardia; Death; Ventricular Tachycardia

  MAUDE report 8783390 ↗
• DeathAug 20, 2018Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  AS REPORTED TO ASCOM (US) INC., IN CUSTOMER COMPLAINT TICKET (B)(4): ON MONDAY (B)(6) 2018 AN ASYSTOLE ALARM WENT OUT TO THE HANDSET DEFINED AS LEVEL 1. THE NURSING STAFF SAID THAT THEY DID NOT GET THE ALARM FOR 4-5 MINUTES. (B)(6), BIOMED AT THE USER FACILITY ((B)(6) MEDICAL CENTER), MENTIONED THAT HE SAW THAT ONLY ONE LEVEL (LEVEL 1) WAS ASSIGNED IN THE SYSTEM WHEN HE CHECKED. HE ALSO SAID THAT THE PATIENT DIED BUT THAT NO EVENT OCCURRED, BECAUSE THE FEMALE PATIENT WAS SICK. THE USER FACILITY ASKED ASCOM TO INVESTIGATE THE LOG FILES.

  Patient problems: Death

  MAUDE report 7800071 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111215. One submission often covers many models, so check the product and lot details in each record.

• Z-1638-2016 · Dec 10, 2015 · Terminated
  Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).