MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS LARGE SWITCHLESS INTERNAL PADDLES

Model Number M1742A

Device Problem Scratched Material (3020)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the internal paddles are scratched.There was no patient or user involvement.

• Brand Name: LARGE SWITCHLESS INTERNAL PADDLES
• Type of Device: NA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS HEALTHCARE - BOTHELL; 22100 bothell-everett hwy; bldg a; bothell WA 98021
• Manufacturer Contact: jacqueline nishino ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8134047
• MDR Text Key: 129465231
• Report Number: 1218950-2018-09488
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K030417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1742A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 11/07/2018
• Supplement Dates FDA Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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