MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER X2

Model Number INTELLIVUE MULTI MEASUREMENT SERVER X2

Device Problems No Audible Prompt/Feedback (2282); Noise, Audible (3273)

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

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information and the complaint is still under investigation.A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported the device indicates a speaker error.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.

Event Description

It was reported the device indicates a speaker error.The device was in clinical use at the time the issue was discovered.  there was no adverse event or patient harm reported.A philips remote service engineer (rse) spoke by telephone support with the customer biomed who indicated upon opening the device identified a lead wire connected to the speaker was broken.The rse recommended to replace the speaker assembly to resolve the issue.The device remains at the customer site.

Manufacturer Narrative

It was reported the device indicates a speaker error.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.A philips remote service engineer (rse) spoke by telephone support with the customer biomed who indicated upon opening the device identified a lead wire connected to the speaker was broken.The rse recommended to replace the speaker assembly to resolve the issue.The device remains at the customer site.

• Brand Name: INTELLIVUE MULTI MEASUREMENT SERVER X2
• Type of Device: INTELLIVUE MULTI MEASUREMENT SERVER X2
• 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: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16252098
• MDR Text Key: 308441340
• Report Number: 9610816-2023-00048
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000261
• UDI-Public: 00884838000261
• 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: 01/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INTELLIVUE MULTI MEASUREMENT SERVER X2
• Device Catalogue Number: M3002A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Date Device Manufactured: 01/27/2017
• 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