MODEL 500EXL INFANT MONITOR 500 EXL 0500FAA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-29 for MODEL 500EXL INFANT MONITOR 500 EXL 0500FAA manufactured by Corometrics Medical Systems, Inc..

Event Text Entries

[123953] The caregiver phoned the account and reported that the monitor was on an infant and did not alarm. The monitor passed alarm tests at the account. The account noted that the reset switch did not clear the alarm lights.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1216774-1998-00002
• MDR Report Key: 147113
• Date Received: 1998-01-29
• Date of Report: 1998-01-08
• Date Mfgr Received: 1998-01-08
• Device Manufacturer Date: 1996-03-01
• Date Added to Maude: 1998-02-05
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RESPIRATORY THERAPIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MODEL 500EXL INFANT MONITOR
• Generic Name: ECG/RESPIRATION MONITOR
• Product Code: KXN
• Date Received: 1998-01-29
• Returned To Mfg: 1998-01-12
• Model Number: 500 EXL
• Catalog Number: 0500FAA
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 143373
• Manufacturer: COROMETRICS MEDICAL SYSTEMS, INC.
• Manufacturer Address: 61 BARNES PARK RD., NORTH WALLINGFORD CT 064920333 US
• Baseline Brand Name: MODEL 500EXL INFANT MONITOR
• Baseline Generic Name: ECG/RESPIRATION MONITOR
• Baseline Model No: 500 EXL
• Baseline Catalog No: 0500FAA
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0		1998-01-29