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

Model Number 91496

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2022

Event Type  Death  

Event Description

Module was placed into suspend processing to permit unspecified patient testing.Suspend processing mode allows the user to remove the patient from the monitor or temporarily pause active monitoring.While in suspend processing mode, alarms are not active.Upon return from testing, the patient was reconnected to the module.The customer indicated that the user saw the presence of waveforms and assumed that the module automatically resumed processing; however, the waveforms were displayed as the patient was reconnected but the module did not resume processing as it was still in suspend process mode.This is normal and expected operation of the system, as documented in the instructions for use.The patient expired while the module was in suspend processing.No alarms generated.

Manufacturer Narrative

The customer was contacted by the spacelabs healthcare customer care manager to gather additional information around the reported event.The customer biomedical engineer evaluated the reported system, the device passed all testing.Spacelabs service personnel reviewed the product and associated logs and data and confirmed that the device operated as intended.Subsequent versions of the product do not display the waveforms until the user removes the product form suspend processing status.Spacelabs healthcare will continue to investigate the reported event and additional information will be submitted in accordance with 21 cfr 803.56 when available.

Manufacturer Narrative

Spacelabs healthcare has launched a recall to notify users of the differences in software functionality to reduce the possibility of user error.Full complete fca number: 3010157426-03/02/2023-00001-c.

• Brand Name: SPACELABS ULTRAVIEW SL COMMAND MODULE
• Type of Device: ULTRAVIEW SL MULTIPARAMETER MODULE
• Manufacturer (Section D): SPACELABS HEALTHCARE; 35301 se center st.; snoqualmie WA 98065
• Manufacturer (Section G): SPACELABS HEALTHCARE; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: whitney snyder ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635701
• MDR Report Key: 14896084
• MDR Text Key: 295218903
• Report Number: 3010157426-2022-00015
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K103142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 91496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 07/01/2022
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 3010157426-03/02/2023-00
• Patient Sequence Number: 1
• Patient Outcome(s): Death