JERON EXECUTIVE INFORMATION SYSTEM 6893

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-30 for JERON EXECUTIVE INFORMATION SYSTEM 6893 manufactured by Jeron.

Event Text Entries

[3024679] Clinical personnel responded initially to a telemetry alarm due to pts bradycardia. At that time, the pt was observed to be disconnected from the oxygen source t-piece with the pulse ox probe on the floor. The first responders stated there was no alarm sounding outside of the room and that the pulse ox inside of the room also was not alarming. The testing of the pulse ox cable and pulse ox by bio med indicated that the pulse ox operated as designed all connections were sound and alarms were easily reproduced. The pulse ox was in the pulse search mode at the time of the event; however it did not trigger an outside alarm over door or at nurses station as expected. The review of the jeron nurse call system alarm records also did not correlate with the number of alarms produced by the pulse ox machine report. At the time of the event, testing the pulse ox connections indicated that cord out alarm did not work once. Once it was re-tested, it worked properly. This indicated a possible connections problem either within the cable, the headwall outlet or the connection between the two.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5027490
• MDR Report Key: 2823057
• Date Received: 2012-10-30
• Date of Report: 2012-10-30
• Date of Event: 2012-10-18
• Date Added to Maude: 2012-11-13
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: JERON EXECUTIVE INFORMATION SYSTEM
• Generic Name: CALL LIGHT SYSTEM
• Product Code: ILQ
• Date Received: 2012-10-30
• Model Number: 6893
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: JERON
• Manufacturer Address: CHICAGO IL US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-10-30