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

Model Number 91496

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Spacelabs received on august 19th, 2020 that a patient had a minor burn to the arm.Spacelabs received new information on september 8th, 2020 a picture with the customer¿s severity of the injury.

Manufacturer Narrative

The investigation confirmed the damaged to the spo2 cable.Service repair technician replaced a faulty/damaged pcba front panel and a broken plastic connector.The device was tested twice for several hours, reported issue could not be replicated.Neither component heated up.This investigation is considered completed and close.Placeholder.

• 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
• MDR Report Key: 10525426
• MDR Text Key: 206717460
• Report Number: 3010157426-2020-00030
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): Y
• PMA/PMN Number: K103142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/05/2021

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: 91496
• Device Catalogue Number: 700-0792-00
• Was Device Available for Evaluation?: Yes
• 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: 08/19/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 08/19/2020
• Supplement Dates FDA Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 700-0792-00
• Patient Outcome(s): Other