MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS ULTRAVIEW SL COMMAND MODULE; ULTRAVIEW SL MULTIPARAMETER MODULE

Model Number 91496

Device Problem Failure to Transmit Record (1521)

Patient Problems Apnea (1720); Bradycardia (1751)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Spacelabs received a report on august 10th 2020 that on (b)(6) 2020 monitor failed to transmit to central monitor during an apnea and bradycardia episode where the patients heartrate and bats dropped to levels where intervention was necessary.The patient infant required stimulation and oxygen.

Manufacturer Narrative

The hospital onsite biomed tested the module all functions worked properly, and it alarmed at central.Findings onsite showed the ecg alarms had been turned off.There was no device malfunction found.This report is complete, and this particular issue is considered closed.

• Brand Name: SPACELABS ULTRAVIEW SL COMMAND MODULE
• Type of Device: ULTRAVIEW SL MULTIPARAMETER MODULE
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• MDR Report Key: 10419513
• MDR Text Key: 204697672
• Report Number: 3010157426-2020-00026
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): Y
• PMA/PMN Number: K103142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/16/2020

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: 91496
• 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: 08/10/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1