MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PIIC CLASSIC UPGRADE

Model Number 866117

Device Problem Application Network Problem (2879)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/19/2023

Event Type  malfunction  

Event Description

The customer reported that the central went down on two floors.Patient involvement is unknown.There was no report of patient or user harm.

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.Phone number provided: (b)(6).

Manufacturer Narrative

A philips field service engineer (fse) received a call from the hospital staff requesting advise on telemetry network coverage on two upper floors of the hospital that was not working.The fse performed troubleshooting on the issue via phone with the customer.Results revealed a loss of hospital main power supply to telemetry infrastructure cabinet on third floor.The fse stated that customer resolved issue themselves without need for visit onsite.The cause of the reported problem was due to customer hospital loss of main power source.The reported problem was confirmed.The piic classic upgrade monitor has not caused or contributed to the reported issue.

Event Description

Philips received a complaint on the piic classic upgrade device indicating that "the central went down on two floors." the device was in use on patient at time of event, there was no adverse event reported.

• Brand Name: PIIC CLASSIC UPGRADE
• Type of Device: PIIC CLASSIC UPGRADE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17286785
• MDR Text Key: 318663098
• Report Number: 1218950-2023-00478
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K081983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• 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 Model Number: 866117
• Device Catalogue Number: 866117
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 11/12/2023
• Supplement Dates FDA Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2013
• 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