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

Model Number M3002A

Device Problem No Audible Alarm (1019)

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

Event Date 02/02/2024

Event Type  malfunction  

Manufacturer Narrative

The remote service engineer (rse) asked the customer if there was a complete failure of the loudspeaker, but no additional details were provided.The rse ordered and shipped a replacement speaker to the customer site to resolve the issue.Reporting institution phone number: (b)(6).Reporter phone number: (b)(6).

Event Description

The customer reported a loudspeaker error on the x2;, a complete failure of the loudspeaker.Patient involvement is unknown.There was no report of patient or user harm.

• 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: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 18814644
• MDR Text Key: 337647201
• Report Number: 9610816-2024-00104
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3002A
• Device Catalogue Number: M3002A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• 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