MAUDE Adverse Event Report: PATIENT SAFE SOLUTIONS, INC. PATIENT TOUCH SCANNER GEN 2

Model Number GEN 2

Device Problems Smoking (1585); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2016

Event Type  malfunction  

Event Description

A pt safe solutions pt touch scanner gen 2 was in the charging strip when it popped, sparked and began smoking.

• Brand Name: PATIENT TOUCH SCANNER GEN 2
• Type of Device: PATIENT TOUCH SCANNER GEN 2
• Manufacturer (Section D): PATIENT SAFE SOLUTIONS, INC.; san diego CA 92121
• MDR Report Key: 5496638
• MDR Text Key: 40325022
• Report Number: MW5060873
• Device Sequence Number: 1
• Product Code: MMH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GEN 2
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other