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

Model Number 91387

Device Problem Loss of Power (1475)

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

Event Date 12/21/2016

Event Type  malfunction  

Manufacturer Narrative

The device was sent to spacelabs healthcare for further analysis.The reported problem was verified.The power supply pcba was replaced on the seven year old device.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) 2016, the ultraview sl bedside monitor shut off while in use.No injury was reported 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: daniel herrera ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635631
• MDR Report Key: 6264419
• MDR Text Key: 65630941
• Report Number: 3010157426-2017-00003
• 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: health professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/19/2017

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
• Other Device ID Number: V2.02.06
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2009
• 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