MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC UNKNOWN PATIENT MONITORING PIIC

Model Number UNK238-PIIC

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/19/2022

Event Type  Injury  

Event Description

It was reported that the customer needed assistance with pulling the logs for a patient event from a philips patient information center.

Manufacturer Narrative

Fda procode updated based on information known at this time.Catalog item id and 510k are unknown at this time.A follow up report will be submitted once the investigation is complete.

Manufacturer Narrative

Catalog item id and 510k have been requested but remain unknown due to missing customer response.H3 other text : no response from customer to multiple contact requests.

Event Description

This report is based on information provided by philips remote service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the patient information center (pic) indicating that the customer needed assistance pulling the logs for a patient event.A good faith effort attempt was completed to clarify what, if any, allegation of device failure was made and if any adverse event occurred.No additional information could be provided because the customer could not be reached after multiple attempts by philips remote service personnel.However, the source system indicates that the device was not in use monitoring a patient and no patient or user harm occurred.No functional tests were performed because the customer could not be reached after multiple attempts by philips remote service personnel.Based on the information available, how the device was alleged to have failed, if at all, and the root cause remain undetermined.Due to insufficient information it could not be confirmed if the device failed in any way.Philips is unable to confirm the final disposition of the device because the customer did not respond to multiple requests for additional information.The investigation concludes that no further action is required.

• Brand Name: UNKNOWN PATIENT MONITORING PIIC
• Type of Device: UNKNOWN PATIENT MONITORING PIIC
• 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15630848
• MDR Text Key: 301982931
• Report Number: 1218950-2022-00925
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK238-PIIC
• Device Catalogue Number: UNK238-PIIC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 10/19/2022
• Supplement Dates Manufacturer Received: 12/28/2022
• Supplement Dates FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other