MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MP5; MHX

Model Number M8105A (865024)

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported a ¿speaker malfunction¿ inop.As of (b)(6) 2017, it could not be investigated if the device still had some sound or not.There was no report of an adverse event.The device was used for patient monitoring.

Manufacturer Narrative

It could not be investigated if the device still had some sound or not.Several attempts have been made to gather deeper insights.No further information was made available.The resolution is unknown.A lack of subsequent calls supports that the customer has resolved the problem.The device is considered to be at the customer site.No part information available no further investigation or action is warranted.Patient information and date of incident has been requested and unavailable at this time of report.

• Brand Name: INTELLIVUE MP5
• Type of Device: MHX
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: wendy chadbourne ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6773081
• MDR Text Key: 82159550
• Report Number: 9610816-2017-00236
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M8105A (865024)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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