DUAL ECG MODULE 90418-16, 15796,97,98,99,800,3

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-30 for DUAL ECG MODULE 90418-16, 15796,97,98,99,800,3 manufactured by Spacelabs, Inc.

Event Text Entries

[495] On february 18, 1990, we purchased cardiac monitors in our (7) bed iccu. We have been working continuously for the past six months to correct a monitor problem. On different occasions an artificial pacemaker spike is detected on the monitor. This occurs whether or not the patient has a pacemaker inserted. Mfg. Informedinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding 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. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1096
• MDR Report Key: 1096
• Date Received: 1992-07-30
• Date of Report: 1992-07-16
• Report Date: 1992-07-16
• Date Reported to FDA: 1992-07-16
• Date Added to Maude: 1992-08-20
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DUAL ECG MODULE
• Product Code: LOS
• Date Received: 1992-07-30
• Model Number: 90418-16, 15796,97,98,99,800,3
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 1050
• Manufacturer: SPACELABS, INC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. No Informationnvalid Deathata	1992-07-30