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

Model Number M3002A

Device Problem No Audible Prompt/Feedback (2282)

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

Event Date 04/10/2024

Event Type  malfunction  

Event Description

It was reported the intellivue multi measurement server x2 was presented with an speaker failure.If there was still sound coming from the device is not confirmed.A loss of audio cannot be ruled out based on information currently available.Patient involvement is unknown.There was no report of patient or user harm.

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.E1: reporting institution phone#: (b)(6).E1: reporter phone# :(b)(6).

Manufacturer Narrative

Visual inspection found that the speaker has damaged cables which causes an alarm failure inop to be displayed.At philips bench repair diagnostic/functional testing was performed.The results of functional testing indicate that the equipment is working correctly.Whether sound comes out of the device has not been confirmed.The speaker was replaced.The device was operational after repairs were completed and the device was returned to the customer.

• 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: 19141993
• MDR Text Key: 340739984
• Report Number: 9610816-2024-00208
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000261
• UDI-Public: 00884838000261
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2011
• 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