PADCALL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-10 for PADCALL manufactured by Curbell Medical Products, Inc.

Event Text Entries

[119661866] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7859576
MDR Report Key7859576
Date Received2018-09-10
Date of Report2018-08-22
Date of Event2018-07-18
Report Date2018-08-22
Date Reported to FDA2018-08-22
Date Reported to Mfgr2018-09-10
Date Added to Maude2018-09-10
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePADCALL
Generic NameSYSTEM, COMMUNICATION, POWERED
Product CodeILQ
Date Received2018-09-10
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCURBELL MEDICAL PRODUCTS, INC
Manufacturer Address20 CENTRE DR ORCHARD PARK NY 14127 US 14127


Patients

Patient NumberTreatmentOutcomeDate
10 2018-09-10

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