MARQUETTE CD TELEMETRY CABINET UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-01-21 for MARQUETTE CD TELEMETRY CABINET UNKNOWN manufactured by Marquette Electronics, Inc..

Event Text Entries

[21514359] Pt found to have been discharged from central telemetry unit. This 76 yr old indian female was admitted for cva, was s/p pacemaker insertion, being monitored on the telemetry unit at approximately 3:28 p. M. A strip (ekg) was run on this patient. At approx. 6 p. M. Patient found to be unresponsive and with palpable pulse. On inspection of equipment patient found to be discharged from the central telemetry unit & data on the patient was irretrievable. Patient was appropriately connected. Four specific steps are necessary to discharge the patient. Staf is very familar with equipment & deny discharging patient inadvertentlydevice not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-sep-91. Service provided by: manufacturer. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, computer software performance tests conducted, electrical tests performed, performance tests performed. Results of evaluation: none or unknown, none or unknown, none or unknown, telemetry equipment. Conclusion: device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device repaired and put back in service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 374
• MDR Report Key: 374
• Date Received: 1992-01-21
• Date of Report: 1991-12-11
• Date of Event: 1991-11-29
• Date Facility Aware: 1991-11-29
• Report Date: 1991-12-11
• Date Reported to FDA: 1991-12-11
• Date Added to Maude: 1992-04-21
• 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: MARQUETTE
• Generic Name: PATIENT TELEMETRY SYSTEM
• Product Code: GYE
• Date Received: 1992-01-21
• Model Number: CD TELEMETRY CABINET
• Catalog Number: UNKNOWN
• ID Number: UNKNOWN
• Operator: OTHER
• Device Availability: Y
• Device Age: 01-SEP-89
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 368
• Manufacturer: MARQUETTE ELECTRONICS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-01-21