MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH SERIES 50IP-2 INTRAPARTUM FETAL MONITOR

Model Number 862337

Device Problem Device Alarm System (1012)

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

Event Date 06/30/2021

Event Type  malfunction  

Event Description

The customer alleged that the alarm of the fetal monitor has alarmed inside the room, but the alarm has not alarmed in the perinatal central.The device was not in use on a patient at the time of event, there was no adverse event reported.

Event Description

The customer alleged that the alarm of the fetal monitor has alarmed inside the room, but the alarm has not alarmed in the perinatal central.The device was not in use on a patient at the time of event, there was no adverse event reported.

• Brand Name: SERIES 50IP-2 INTRAPARTUM FETAL MONITOR
• Type of Device: SERIES 50IP-2 INTRAPARTUM FETAL MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• MDR Report Key: 12167944
• MDR Text Key: 263458542
• Report Number: 9610816-2021-10223
• Device Sequence Number: 1
• Product Code: HFM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup

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: No Information
• Device Model Number: 862337
• Device Catalogue Number: 862337
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1