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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WELCH ALLYN, INC. WELCH ALLYN CONNEX 6800 VITAL SIGNS MONITOR; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
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WELCH ALLYN, INC. WELCH ALLYN CONNEX 6800 VITAL SIGNS MONITOR; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) Back to Search Results
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Event Description
Welch allyn connex 6800 vital signs monitor fell off the wall mounted arm and adapter bracket.This is the 3rd time in 4 months that this has occurred in one patient care area (floor a1) which has 28 of these wall mounted monitors.It appears that over time, through normal manipulation of the monitor, the thumbscrew, that secures the monitor to the bracket, loosens and the bracket becomes bent.This allows the monitor to release from the bracket and fall.These are mounted at the head of the patient bed and can fall on patients and clinical staff.One of the 3 that has recently fallen, injured a nurse.In another inpatient area (floor a2), the mounting brackets on 6 of the 30 monitors had to be replaced during the month of (b)(6) 2024 to prevent these monitors from falling.Reference reports: mw5153905, mw5153906.
 
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Brand Name
WELCH ALLYN CONNEX 6800 VITAL SIGNS MONITOR
Type of Device
MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
Manufacturer (Section D)
WELCH ALLYN, INC.
MDR Report Key19126077
MDR Text Key340544848
Report NumberMW5153907
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 04/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/16/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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