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U.S. Department of Health and Human Services

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

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PATIENT SAFE SOLUTIONS, INC. PATIENT TOUCH SCANNER GEN 2 Back to Search Results
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.

 
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Brand NamePATIENT TOUCH SCANNER GEN 2
Type of DevicePATIENT TOUCH SCANNER GEN 2
Manufacturer (Section D)
PATIENT SAFE SOLUTIONS, INC.
san diego CA 92121
MDR Report Key5496638
MDR Text Key40325022
Report NumberMW5060873
Device Sequence Number1
Product Code MMH
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
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 Received03/09/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberGEN 2
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/09/2016 Patient Sequence Number: 1
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