MAUDE Adverse Event Report: MOBILEHELP LLC MEDICAL ALERT EMERGENCY CALL SYSTEM; SYSTEM, COMMUNICATION, POWERED

Model Number MOBILE HELP SOLO

Device Problems Defective Alarm (1014); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 10/10/2021

Event Type  Injury  

Event Description

I have type 1 diabetes and a history of severe seizures, making an emergency medical alert system vital.I use mobile help and wear a neck pendant with fall detection.Mobile help recommends testing the pendant monthly by dropping the pendant on the floor to simulate a fall.On or about (b)(6) 2021 the pendant failed to alert until the 3rd drop.For about 10 to 15 minutes the system repeatedly announce that a fall was detected and they were contacted emergency personnel, then the call disconnected.Approximately 20 minutes later i received a response from mobile help asking what my emergency was.This made no sense as i had not made any further tests.When i explained what happened to the woman, she said that their records did not show a previous distress call.Obviously, if had been a genuine emergency instead of a test, the result could have been catastrophic.I called mobile help on (b)(6) 2021 at approximately 12:55 pm and reported the incident to (b)(6) and canceled my membership and switched to a different medical alert system.Mobile help's phone number is (b)(4) ; address (b)(4).My name is (b)(6).Fda safety report id# (b)(4).

• Brand Name: MEDICAL ALERT EMERGENCY CALL SYSTEM
• Type of Device: SYSTEM, COMMUNICATION, POWERED
• Manufacturer (Section D): MOBILEHELP LLC
• MDR Report Key: 12751268
• MDR Text Key: 280533021
• Report Number: MW5105126
• Device Sequence Number: 1
• Product Code: ILQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MOBILE HELP SOLO
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ANTACIDS; ANTI-SEIZURE MED; ANTIDEPRESSANTS; ATORVASTATIN; CANE ; CGM; HIGH BLOOD PRESSURE MEDICATION; INSULIN PUMP; LEVO THYROXINE; WALKER
• Patient Outcome(s): Life Threatening
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White