MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS AVALON FM50 FETAL MONITOR; PERINATAL MONITORING SYSTEM

Model Number M2705A

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer reported that "on the (b)(6) 2015 the 865071 (m2705a) avalon fm50 fetal monitor s/n: (b)(4) had changed alarm mode from all alarms to inop only mode and did not alarm.This caused delay to treatment since status was not noticed immediately.Per head nurse no harm for the baby occurred on potentially dangerous event".

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.(b)(4).

Event Description

The customer reported that "on the (b)(6) 2015, the 865071 (m2705a) avalon fm50 fetal monitor, s/n: (b)(4) had changed alarm mode from all alarms to inop only mode and did not alarm.This caused delay to treatment since status was not noticed immediately.Per head nurse, no harm for the baby occurred on potentially dangerous event".

• Brand Name: AVALON FM50 FETAL MONITOR
• Type of Device: PERINATAL MONITORING SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; böeblingen 71034 ; GM 71034
• Manufacturer Contact: wendy chadbourne ; hewlett-packard str.2; böeblingen 71034 ; GM 71034
• MDR Report Key: 4934698
• MDR Text Key: 17697243
• Report Number: 9610816-2015-00136
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K071800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2015

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: M2705A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/03/2015
• Initial Date FDA Received: 07/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2014
• 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