MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON FM20 FETAL MONITOR

Model Number M2702A

Device Problems Device Alarm System (1012); Defective Alarm (1014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2021

Event Type  malfunction  

Event Description

The customer reported that some alarms are not working.No further information regarding the reported issue was available at the time of the reporting decision.The device was not in use on a patient at the time of the reported issue.No death, or patient/user injury or harm was reported.

Event Description

The customer reported that some alarms are not working.The device was not in use on a patient at the time of the reported issue.No death, or patient/user injury or harm was reported.

• Brand Name: AVALON FM20 FETAL MONITOR
• Type of Device: AVALON FM20 FETAL MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• MDR Report Key: 12149739
• MDR Text Key: 260973504
• Report Number: 9610816-2021-10217
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838000407
• UDI-Public: 00884838000407
• Combination Product (y/n): N
• PMA/PMN Number: K140535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2702A
• Device Catalogue Number: M2702A
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/02/2021
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1