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

Model Number 91496

Device Problem Device Alarm System (1012)

Patient Problems Apnea (1720); Bradycardia (1751); Death (1802)

Event Date 02/15/2016

Event Type  Death  

Manufacturer Narrative

Spacelabs is evaluating this occurrence and will file a supplemental report once our evaluation is concluded.

Event Description

Spacelabs received a report that the nursing staff transferred a patient in er (b)(4) to a transport monitor without following protocol and obtaining the required help from the biomedical department.The patient later experienced a bradycardia and apnea event and coded.The nursing staff reported no alarm was heard from the patient's room (no one was in the room) or from the central station.The patient subsequently died.

Manufacturer Narrative

Onsite investigation of the involved devices conducted by a spacelabs field service engineer confirmed that the equipment performed to specifications.The investigation was witnessed by a facility staff member.Spacelabs confirmed that there were no technical problems with the device.The issue reported was the result of hospital staff not following their own protocol and obtaining the required help from their biomedical department; the device was not configured for the emergency department network.This report is considered final and the issue closed.

• Brand Name: SPACELABS ULTRAVIEW SL COMMAND MODULE
• Type of Device: ULTRAVIEW SL 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: 5512292
• MDR Text Key: 40726075
• Report Number: 3010157426-2016-00021
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/17/2016

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: 91496
• Other Device ID Number: V2.01.12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 03/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2016
• 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
• Patient Outcome(s): Death
• Patient Weight: 76