MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX700 PATIENT MONITOR

Model Number 865241

Device Problem No Audible Prompt/Feedback (2282)

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

Event Date 12/06/2023

Event Type  malfunction  

Event Description

The customer reported speaker malfunction inop.The device was in use at time of event, there was no adverse event reported.

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Manufacturer Narrative

Philips received a complaint on the intellivue mx700 patient monitor indicating that there was a speaker malfunction.A good faith effort (gfe) was performed to clarify if the customer was alleging sound issues with the speaker or only a speaker malfunction inop on the monitor, but no additional information was provided.The device was sent to philips bench repair.A philips bench repair technician (brt) evaluated the device and was unable to confirm the issue.No speaker malfunction error was appearing on screen.The brt confirmed that sound was emitting from the device properly at different volumes.There was no trouble with the device during testing.Based on the information available and the testing conducted philips was unable to replicate the reported problem.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.The brt replaced the speaker for preventative measure.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Event Description

The customer reported a speaker malfunction inop.It is unknown if sound was still coming from the device.The device was in use at time of event, there was no adverse event reported.

• Brand Name: INTELLIVUE MX700 PATIENT MONITOR
• Type of Device: INTELLIVUE MX700 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 18418422
• MDR Text Key: 331599429
• Report Number: 9610816-2023-00692
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838029088
• UDI-Public: 00884838029088
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• 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: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865241
• Device Catalogue Number: 865241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2018
• 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