MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS ULTRAVIEW 1700 MONITOR; ULTRAVIEW MULTIPARAMETER MONITOR

Model Number 90387

Device Problem Failure to Sense (1559)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Spacelabs received a report that on (b)(6) 2017, a loss of telemetry monitoring occurred at the central station.No one was injured as a result of this event.

Manufacturer Narrative

A spacelabs field service engineer arrived onsite for further analysis of the problem.The fse determined that the cause of the problem was not the module housing which was listed on the initial report, but was that the fourteen year old central station was no longer communicating with the module housing.The customer was already in the process of purchasing a newer central monitor, so a loaner device was placed into service until the customer¿s new monitor arrived.This report is complete and this particular issue is considered closed.

• Brand Name: SPACELABS ULTRAVIEW 1700 MONITOR
• Type of Device: ULTRAVIEW MULTIPARAMETER 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: 6694248
• MDR Text Key: 79591117
• Report Number: 3010157426-2017-00053
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2017
• 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?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1