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

Model Number	866212
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem 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 or Problem 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
• Common Device Name: 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
• Report Number: 1218950-2023-00016
• Device Sequence Number: 3364223
• Product Code: MHX
• UDI-Device Identifier: 00884838038875
• UDI-Public: 00884838038875
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K041741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• 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
• Operator of Device: Health Professional
• Device Model Number: 866212
• Device Catalogue Number: 453564195161
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2022
• Supplement Date Received by Manufacturer: 12/18/2022
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown