MAUDE Adverse Event Report: NEOVENTA MEDICAL AB STAN S31 FETAL HEART MONITOR; HEO: OBSTETRIC DATA ANALYZER

Model Number STAN S31

Device Problem Loss of Power (1475)

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

Event Date 03/05/2014

Event Type  malfunction  

Event Description

The system is intermittently shutting down which is causing inconvenience.

Manufacturer Narrative

The system is intermittently shutting down which is causing inconvenience.Awaiting the device for further investigation.No harm to pt reported and no add'l treatment needed.

• Brand Name: STAN S31 FETAL HEART MONITOR
• Type of Device: HEO: OBSTETRIC DATA ANALYZER
• Manufacturer (Section D): NEOVENTA MEDICAL AB; moeindal ; SW
• Manufacturer Contact: linda jonsson ; norra agatan 32; moeindal 43135 ; SW 43135 ; 17583200
• MDR Report Key: 3994432
• MDR Text Key: 19799052
• Report Number: 3004729605-2014-00002
• Device Sequence Number: 1
• Product Code: HEO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P020001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2014

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: STAN S31
• Device Catalogue Number: SYS101003
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2014
• Initial Date FDA Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2012
• 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