MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX40 2.4GHZ

Model Number 865351

Device Problem No Audible Alarm (1019)

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

Event Date 12/19/2023

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.(b)(6).

Event Description

The customer reported a speaker failure occurred.At the time of the report, it was unknown if the device displayed an error message with sound, or if the speaker did not produce any sound.It is unknown if the device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.

Manufacturer Narrative

After a vigilance report specialist and manager review of additional information provided, it was determined that this record is no longer reportable.The initial report/case which was received leading to the creation of this complaint record, was found to have been opened in error under the incorrect customer site.A new record was created and submitted, where it was confirmed that there was a speaker malfunction, but sound was still produced.

• Brand Name: INTELLIVUE MX40 2.4GHZ
• Type of Device: INTELLIVUE MX40 2.4GHZ
• 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: 18394641
• MDR Text Key: 331342738
• Report Number: 1218950-2023-00971
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865351
• Device Catalogue Number: 865351
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/08/2023
• 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