MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS; SQUARE PREATTACHED LEADWIRE ELECTRODE

Model Number 13953B

Device Problem Gel Leak (1267)

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

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

The customer reported that the gel separated from the electrode, the child put the gel into his mouth.There was no reported patient impact.

• Brand Name: NA
• Type of Device: SQUARE PREATTACHED LEADWIRE ELECTRODE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8663110
• MDR Text Key: 146915760
• Report Number: 1218950-2019-03660
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 20884838006793
• UDI-Public: (01)20884838006793
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 13953B
• Device Catalogue Number: 989803100551
• Device Lot Number: 805441 2019-08-28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1