MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS OB TRACEVUE HARDWARE BUNDLES

Model Number M1383E

Device Problem Fire (1245)

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 that a display that was in use "caught fire".Limited details have been provided about the occurrence.No harm has been reported.

Manufacturer Narrative

A 17 inch lcd display in use at the customer site with their ob tracevue obstetrical system malfunctioned and shut off.The display could not be powered on again prompting the customer to contact philips for replacement.Though initially information provided indicated that a fire had occurred involving the device; philips has since confirmed there was in fact no smoke, fire or flame associated with this failure.The customer has been provided with a replacement display and has indicated they have scrapped the original display.No further action or investigation is warranted.

• Brand Name: OB TRACEVUE HARDWARE BUNDLES
• Type of Device: NA
• 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: betty harris ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 7538828
• MDR Text Key: 109250492
• Report Number: 9610816-2018-00128
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K970456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1383E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2006
• 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