COROMETRICS COROMETRICS 118 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-09-22 for COROMETRICS COROMETRICS 118 * manufactured by Ge Medical Systems/marquette.

Event Text Entries

[213985] Add'l info rec'd from mfr 11/13/00: in performing a risk assessment, it was determined that, in order, for data to be sent to the wrong bed, three simultaneous events must occur -(1) the monitors must be on a corolan network; (2) address checking in the monitors / wallplates is not turned on; and (3) a hardware failure in the corolan or the cables must occur. Since the likelihood of all three events occurring simultaneously is small, the probability of occurrence is negligible. As discussed above, the hosp qs system has been installed for over 5 years and previously had not reported problems of this nature. It is likely that stresses were placed on the cables or monitors, causing a hardware failure (open address lines). Mfr's info technologies' svc went to the facility to verify that the monitors, cables, wallplates, etc. Were working properly while the monitor and corolan network continued to be used at hosp. No problems were found. In response to the customer request, svc has completed the process of replacing the corolan network with a serial monitoring network.
Patient Sequence No: 1, Text Type: D, B5

[19149658] Data from the fetal monitors is being incorrectly placed in the electronic charting system. Data is being transposed from one pt to another - e. G. , bed #1 data may be incorrectly assigned to bed #2.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1020004
• MDR Report Key: 297738
• Date Received: 2000-09-22
• Date of Report: 2000-09-22
• Date Added to Maude: 2000-09-28
• 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: 0
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: COROMETRICS
• Generic Name: FETAL MONITOR
• Product Code: KXN
• Date Received: 2000-09-22
• Model Number: COROMETRICS 118
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 288196
• Manufacturer: GE MEDICAL SYSTEMS/MARQUETTE
• Manufacturer Address: PO BOX 414 MILWAUKEE WI 532010414 US

Device Sequence Number: 2

• Brand Name: QMI
• Generic Name: ELECTRONIC CHARTING
• Product Code: DSF
• Date Received: 2000-09-22
• Model Number: QMI
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 288199
• Manufacturer: GE MEDICAL SYSTEMS/MARQUETTE
• Manufacturer Address: PO BOX 414 MILWAUKEE WI 532010414 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2000-09-22