MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SMART PADS III, 1 SET

Model Number 861389

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

The customer reported that an error occurred and the equipment cannot be used.There was no negative patient impact.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Replacement pads resolved the issue.

• Brand Name: SMART PADS III, 1 SET
• Type of Device: SMART PADS III
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021 8431
• Manufacturer Contact: betty harris ; 22100 bothell everett hwy; bothell, WA 98021-8431
• MDR Report Key: 4856694
• MDR Text Key: 5851792
• Report Number: 3030677-2015-01496
• Device Sequence Number: 1
• Product Code: MLN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2015
• Device Model Number: 861389
• Device Lot Number: 30628-0784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1