MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MULTI MEASUREMENT SERVER X2; PATIENT MONITOR

Model Number M3002A

Device Problems No Audible Prompt/Feedback (2282); Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported loudspeaker defective.No additional information was available at time of report to determine if there was still sound coming from the device.The device was not used for patient monitoring at the time of the alleged malfunction.

Manufacturer Narrative

Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Event Description

The customer reported loudspeaker defective.The device was not used for patient monitoring at the time of the alleged malfunction.

• Brand Name: INTELLIVUE MULTI MEASUREMENT SERVER X2
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 11072060
• MDR Text Key: 224396911
• Report Number: 9610816-2020-00477
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K071426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 12/24/2020
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1