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

Model Number 90496

Device Problem Device Alarm System (1012)

Patient Problem Ventricular Tachycardia (2132)

Event Date 06/25/2016

Event Type  malfunction  

Manufacturer Narrative

The involved devices were tested and all the equipment performed to specifications.The retrospective patient data was sent to spacelabs for evaluation.Spacelabs will file a supplemental report once the investigation is complete.

Event Description

Spacelabs received a report that on (b)(6) 2016 at 6:28 am, an eight beat run of ventricular tachycardia (vtach) did not alarm at bedside or central, but was captured in clinical access (the retrospective database application).No one was injured as a result of this event.

Manufacturer Narrative

Onsite testing of the involved devices by a spacelabs field service engineer confirmed the equipment performed to specifications.The testing was witnessed by a facility staff member.The patient retrospective database was provided by the customer for review by a spacelabs software lead engineer.The reported 8 beat run at 06:28 on (b)(6) 2016 is not present in the ecg waveforms.Between a ventricular triplet at 05:49am and a 4 beat run at 06:57am, there are only single isolated pvc¿s.The reported event did not meet the criteria for a run alarm, which is 5 or more ventricular beats in a row, thus no alarm was generated.Based upon the investigation, we have concluded that the device did not malfunction.This investigation is considered complete and the issue closed.

• Brand Name: SPACELABS ULTRAVIEW COMMAND MODULE
• Type of Device: ULTRAVIEW MULTIPARAMETER MODULE
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: john zeng ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635915
• MDR Report Key: 5824776
• MDR Text Key: 51130112
• Report Number: 3010157426-2016-00054
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2016

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: 90496
• Other Device ID Number: V1.02.12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2016
• Initial Date FDA Received: 07/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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