MAUDE Adverse Event Report: SPACELABS HEALTHCARE, INC. SPACELAB SP02 MONITOR AND CABLE; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS

Catalog Number 700-0792-00

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

Patient Problem Burn, Thermal (2530)

Event Date 08/17/2020

Event Type  malfunction  

Event Description

Spacelab sp02 cable was lying across patient's left forearm.Cable found to be hot to the touch.Burn on patient's left forearm in the shape of the cable was found.Therapy dates: (b)(6) 2020 - (b)(6) 2020.Fda safety report id# (b)(4).

• Brand Name: SPACELAB SP02 MONITOR AND CABLE
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS
• Manufacturer (Section D): SPACELABS HEALTHCARE, INC. ; snquaimie WA 98065
• MDR Report Key: 10540199
• MDR Text Key: 207331386
• Report Number: MW5096650
• Device Sequence Number: 1
• Product Code: MHX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/11/2020

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 Catalogue Number: 700-0792-00
• Device Lot Number: CMT 06/18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 91