CODE ALERT SYSTEM CA2000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-28 for CODE ALERT SYSTEM CA2000 manufactured by R.f. Technologies, Inc..

Event Text Entries

[17435902] Aalert system to alert nurses and staff/resident is entering an unrestricted area. Alert alarm did not sound. At lunch time 12:00, resident was eating, all staff were in dining room feeding other 42 residents when resident involved left his table when he was finished eating. The resident is sitting in a wheelchair, went to the door with the code alert system attached installed, opened the door and went through, at which time the code alert system failed because the resident involved was wearing a bracelet on the ankle which activates the alert system. The alert szystem should have alarmed the staff. The door is not vivisle from the staff at time of feeding other residents. Resident fell down stairs behind unauthorized area pronounced dead at the sceneinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Device was evaluated after the event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number5238
MDR Report Key5238
Date Received1993-04-28
Date of Report1993-04-21
Date of Event1993-04-18
Report Date1993-04-21
Date Reported to Mfgr1993-04-19
Date Added to Maude1993-07-01
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCODE ALERT SYSTEM
Generic NameCA2000 SINGLE CONTROL UNIT
Product CodeFFI
Date Received1993-04-28
Model NumberCA2000
Device Expiration Date1992-03-01
Device Availability*
Device Age01-MAR-92
Implant Flag*
Device Sequence No1
Device Event Key4938
ManufacturerR.F. TECHNOLOGIES, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Death 1993-04-28

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