MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS OBTV REV G ADVANCED SYSTEM SW ONLY; PERINATAL MONTIORING SYSTEM

Model Number 865342

Device Problem Defective Alarm (1014)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported alarms on ob tracevue are not working.No patient invovlement.

• Brand Name: OBTV REV G ADVANCED SYSTEM SW ONLY
• Type of Device: PERINATAL MONTIORING SYSTEM
• 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: 8784273
• MDR Text Key: 150971288
• Report Number: 9610816-2019-00172
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865342
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2011
• 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