FDA Adverse Event Death Summary report: N

SPACELABS XHIBIT CENTRAL STATION

MDR report key: 11720483 · Received April 23, 2021

Report

Report Number: 3010157426-2021-00023
Event Type: Death
Date Received: April 23, 2021
Date of Event: April 13, 2021
Report Date: August 27, 2021
Manufacturer: SPACELABS HEALTHCARE INC.
Product Code: MHX
PMA / PMN Number: K122146
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

SPACELABS INVESTIGATION FOUND NO FAILURE. THE ICS DATABASE AND XHIBIT LOGS WERE ANALYZED. THE INVESTIGATION FOUND PATIENT WAS NOT CONNECTED TO SPACELABS MONITORING EQUIPMENT. THE HOSPITAL STAFF ORIGINALLY REPORTED THE DECEASED PATIENT WAS CONNECTED TO DEVICE 1421T BUT THE PRESENCE OF WAVEFORMS DURING AND AFTER THE TIME THE DECEASED PATIENT WAS FOUND SUGGESTS THIS DEVICE WAS CONNECTED TO A DIFFERENT PATIENT. ON (B)(6) 2021, THE DATABASE BACKUP SHOWS THERE WERE 12 PATIENTS ADMITTED TO THE 7 BLUM TELEMETRY UNIT WHEN THE DECEASED PATIENT WAS FOUND. EACH OF THESE PATIENT RECORDS WERE REVIEWED AND THERE IS NO EVIDENCE THAT ANY EXPIRED WHILE CONNECTED TO THE SPACELABS MONITORING EQUIPMENT. THE FSE WENT ON-SITE ATTEMPTED TO TEST ALL PRODUCTS WHICH WAS NOT POSSIBLE, AS THE DEVICE WAS UNKNOWN. THIS REPORT IS COMPLETE, AND THIS ISSUE IS CONSIDERED CLOSED. H3 OTHER TEXT : PLACEHOLDER.

Additional Manufacturer Narrative · 1

SPACELABS HAS LAUNCHED AN INVESTIGATION AND WILL FILE A SUPPLEMENTAL REPORT WHEN THE INVESTIGATION IS COMPLETE.

Description of Event or Problem · 1

SPACELABS RECEIVED A REPORT THAT ON (B)(6) 2021 A FAILURE TO ALARMS ON THE MONITOR SYSTEM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
617557	SPACELABS XHIBIT CENTRAL STATION	XHIBIT CENTRAL MONITOR	MHX	SPACELABS HEALTHCARE INC.	96102

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death