MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS ULTRAVIEW PATIENT MONITOR; MULTIPARAMETER PATIENT MONITOR

Model Number 91387

Device Problems Use of Incorrect Control/Treatment Settings (1126); Loss of Power (1475)

Patient Problem No Information (3190)

Event Date 05/16/2017

Event Type  malfunction  

Manufacturer Narrative

A spacelabs field service engineer arrived at the site for further evaluation of the device.The reported problem was verified on the eleven year old device, and the power supply pcba was replaced.The repaired unit passed all functional tests and was restored to service.This report is complete and this particular issue is considered closed.

Event Description

Spacelabs received a report that on (b)(6) 2017, a central station monitoring telemetry patients lost power and turned off following a popping sound.The power was restored by replacing the external power supply, however the central monitor's settings became corrupted which caused the device to function as a bedside monitor.No one was injured as a result of this event.

• Brand Name: SPACELABS ULTRAVIEW PATIENT MONITOR
• Type of Device: MULTIPARAMETER PATIENT MONITOR
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: carolyn hosea ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635924
• MDR Report Key: 6639746
• MDR Text Key: 77708777
• Report Number: 3010157426-2017-70050
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/13/2017

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: 91387
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2017
• Initial Date FDA Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1