MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS COMPONENT MONITORING SYSTEM (FLATSCREEN)

Model Number M1167A

Device Problem Device Alarm System (1012)

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

Event Type  malfunction  

Event Description

The customer reported that an alarm in one room was not transferred to the monitor in a different room.No patient harm was reported.

Manufacturer Narrative

Pr#: (b)(4).A follow up report will be submitted upon completion of the investigation.

• Brand Name: COMPONENT MONITORING SYSTEM (FLATSCREEN)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer Contact: denyse murphy ; 3000 minuteman road; andover, MA 01810 ; 9786597844
• MDR Report Key: 3966696
• MDR Text Key: 4635443
• Report Number: 9610816-2014-00152
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K002758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2014

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: M1167A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 06/02/2014
• Was Device Evaluated by Manufacturer?: No
• 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