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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: J. T. POSEY CO. NURSE CALL CABLE

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J. T. POSEY CO. NURSE CALL CABLE Back to Search Results
Model Number 8282
Device Problem Improper Alarm (2951)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
The customer reported the nurse's station sounds inconsistently when the alarm is in use with the nurse call cable, discovered while in use but customer could not provide the date of the event.No pt incident or injury was reported.
 
Manufacturer Narrative
Results: eval found that during testing, the nurse call cable with the alarm, when the nurse call cable is wiggled, the nurse call light toggles on and off at the test fixture.When the nurse call cable is used with a known good alarm, the nurse call led turns on at the nurse call test fixture when there is no weight on the sensor (as expected) and the nurse call led turns off when weight is on the sensor (as expected).However, if the cable is wiggled, the nurse call led light toggles on and off.The nurse call cable was scuff marks on it and one of the jacks is loose.When the nurse call cable was opened, it was found to have a broken ground wire.(b)(4).
 
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Brand Name
NURSE CALL CABLE
Manufacturer (Section D)
J. T. POSEY CO.
arcadia CA
Manufacturer (Section G)
J. T. POSEY CO.
5635 peck rd.
arcadia CA 91006
Manufacturer Contact
pam wampler
5635 peck rd.
arcadia, CA 91006
6264433143
MDR Report Key4101960
MDR Text Key4713053
Report Number2020362-2014-00306
Device Sequence Number1
Product Code KMI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Unknown
Type of Report Initial
Report Date 08/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8282
Device Catalogue Number8282
Device Lot NumberN1147
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/25/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received08/13/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
SITTER ELITE ALARM: MODEL 8345, SN # (B)(4)
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