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

Model Number 91387

Device Problem Device Alarm System (1012)

Patient Problems Death (1802); Ventricular Tachycardia (2132)

Event Date 01/20/2021

Event Type  Death  

Manufacturer Narrative

The fse went on-site tested all products and passed, including both visible and audible alarm notifications.No failure found; device is still actively use at hospital.Spacelabs field service engineer (fse) has made multiple attempts to gather the needed ics database information but was not allowed by hospital.There is not enough information available to determine that a malfunction occurred during this complaint episode.If additional information is provided spacelabs will reassess the investigation.This investigation is considered complete and close.

Event Description

Spacelabs received a report that on (b)(6) 2021 at 12:55 pm on (b)(6) the patient in tele bed t2046 went into vtach and perished because no alarms occurred at the central.A death was reported in association with 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: marc rivas ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635568
• MDR Report Key: 11325660
• MDR Text Key: 231934150
• Report Number: 3010157426-2021-00008
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K102422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/01/2005,02/12/2021

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: 91387
• 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: 01/21/2021
• Initial Date FDA Received: 02/12/2021
• 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
• Patient Outcome(s): Death