MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS XHIBIT CENTRAL STATION; XHIBIT CENTRAL MONITOR

Model Number 96102

Device Problems No Audible Alarm (1019); Disconnection (1171); Battery Problem (2885)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

Spacelabs has launched an investigation and will file a supplemental report when the investigation is complete.

Event Description

Spacelabs received a report that on april 23rd, 2021 the staff claims that no alarm occurred at the central for disconnected leads.When they found the transmitter, the batteries were dead.Patient perished at 13:50 3/30.

Manufacturer Narrative

Spacelabs investigation found no failure.The monitor recognized all electrodes were removed from the patient and generated a medium priority all leads off alarm that is stored in the patient''s ics database record.The hospital staff acknowledged this alarm.The fse witnessed alarm indicators for the central monitor operated according to specifications on his visit.This report is complete, and this issue is considered closed.H3 other text: placeholder.

• Brand Name: SPACELABS XHIBIT CENTRAL STATION
• Type of Device: XHIBIT CENTRAL MONITOR
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• MDR Report Key: 11721162
• MDR Text Key: 250179829
• Report Number: 3010157426-2021-00024
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): Y
• PMA/PMN Number: K122146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96102
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 04/01/2021
• Supplement Dates FDA Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death