MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC EFFICIA CM12

Model Number 863303

Device Problem No Audible Prompt/Feedback (2282)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2021

Event Type  malfunction  

Event Description

The customer contacted the customer care solution center and alleged that the alarm audio was not functioning on the complaint device and requested support.The complaint device was not in clinical use at the time that the issue was discovered.There was no adverse event or patient harm reported.

• Brand Name: EFFICIA CM12
• Type of Device: EFFICIA CM12
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: derek sammarco ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 11405358
• MDR Text Key: 234469386
• Report Number: 1218950-2021-10058
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K151812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: Other
• Device Model Number: 863303
• Device Catalogue Number: 863303
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/15/2021
• Initial Date Manufacturer Received: 02/15/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 02/15/2021
• Supplement Dates FDA Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2020
• 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