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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CURBELL MEDICAL PRODUCTS, INC PADCALL; SYSTEM, COMMUNICATION, POWERED

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CURBELL MEDICAL PRODUCTS, INC PADCALL; SYSTEM, COMMUNICATION, POWERED Back to Search Results
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Fall (1848)
Event Date 07/18/2018
Event Type  malfunction  
Event Description
The patient was sitting in a recliner chair bedside with a chair alarm and call bell on/with patient.Nurse rounded on patient who declined any needs at that time.When the nurse made it out to the nurse desk she heard the chair alarm.She immediately returned to the room and found the patient sliding over the left arm of recliner to the floor.The patient was attempting to get up off the floor.The fall response team was called but there was no response as the time of day had no staff to cover (approx.0630).The patient was assisted to the bed but was insisting on going to the bathroom.The nurse reported that the patient was assisted to the bathroom as he had refused to use the urinal several times during her shift and he continued to refuse to use it.Patient returned from bathroom and nurse attempted to place him in bed but patient refused and was placed back into the chair.Chair alarm was placed on patient again and he was given call bell.At this time nurse found that call bell was not working, nurse claims call bell had been working when he was initially assisted into chair.Engineering was made aware of faulty call bell.
 
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Brand Name
PADCALL
Type of Device
SYSTEM, COMMUNICATION, POWERED
Manufacturer (Section D)
CURBELL MEDICAL PRODUCTS, INC
20 centre dr
orchard park NY 14127
MDR Report Key7859576
MDR Text Key119661866
Report Number7859576
Device Sequence Number1
Product Code ILQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2018
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/22/2018
Event Location Hospital
Date Report to Manufacturer09/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age16060 DA
Patient Weight89
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