MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS MULTIPARAMETER PATIENT MONITOR; COMPACT PORTABLE PATIENT MONITOR

Model Number 863074

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 stated that the unit has a speaker malfunction.There was no patient impact reported.

Manufacturer Narrative

Event Description

The customer stated that the unit has a speaker malfunction.The device was being used on a patient at the time of the event but there was no report of any patient or user impact.

Manufacturer Narrative

Philips rce assisted the customer with troubleshooting.The customer ran an audio test and attempted to clear the patient data; both attempts had failed.The customer checked the wires and found the wires seated well and functioning.Philips technical support advised the customer to replace the speaker and provided the customer with parts id (pn 453564095691, pn 453564031481, and pn 453564208091) to resolve the issue.The device remains at the customer site.Subsequent call (b)(4) was made by the customer to clarify the validity of part id (pn 453564095691); it was confirmed during the call that the part id (pn 453564095691) is valid.There have been no other subsequent calls logged for this device/issue.No further investigation is warranted at this time.

• Brand Name: PHILIPS MULTIPARAMETER PATIENT MONITOR
• Type of Device: COMPACT PORTABLE PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6421233
• MDR Text Key: 70710461
• Report Number: 1218950-2017-01828
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 863074
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2008
• 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