MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS TELE ASSY SMART-HOPPING APC

Model Number 866212

Device Problem Wireless Communication Problem (3283)

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

Event Date 12/18/2022

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer biomedical engineer (biomed) reported that they lost a network switch in a closet and had lost wireless telemetry coverage on the 4th floor.The biomed had the switch go out, but other issues arose after getting it back online; wireless wasn't working properly.The biomed requested a philips technical consultant go onsite.The device was in use at the time the issue was discovered.There was no adverse event or patient harm reported.

Event Description

The customer biomedical engineer (biomed) reported that they lost a network switch in a closet and had lost wireless telemetry coverage on the 4th floor.The biomed had the switch go out, but other issues arose after getting it back online; wireless wasn't working properly.The biomed requested a philips technical consultant (tc) go onsite.The device was in use at the time the issue was discovered.There was no adverse event or patient harm reported.The tc went onsite, and found the wireless network down; the tc was unable to resolve the issue.The next day the tc contacted philips national service support (nss) for assistance.It was determined that the root cause of the problem was a bad master sync switch on the 2nd floor.The master sync switch failure affected the access point controller (apc) in the closet, which constantly caused the network access points (aps) to resync all of the time over and over.Replacing the sync switch with a good sync switch allowed the telemetry packs to associate again.

• Brand Name: TELE ASSY SMART-HOPPING APC
• Type of Device: TELE ASSY SMART-HOPPING APC
• 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: 16129922
• MDR Text Key: 308546851
• Report Number: 1218950-2023-00016
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038875
• UDI-Public: 00884838038875
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866212
• Device Catalogue Number: 453564195161
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2017
• 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