MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; MONITOR,M3,BP,SPO2,ORAL TEMP

Catalog Number MDSM3SNTC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2022

Event Type  malfunction  

Manufacturer Narrative

According to the facility the vitals monitor sparked and began to smoke.No additional information is available at this time.The sample is available but has not been returned for evaluation.No additional information is available at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the facility the vitals monitor sparked and began to smoke.

• Type of Device: MONITOR,M3,BP,SPO2,ORAL TEMP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15726203
• MDR Text Key: 303243882
• Report Number: 1417592-2022-00214
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MDSM3SNTC
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other