MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH SERIES 50A ANTEPARTUM FETAL MONITOR

Model Number 862336

Device Problem No Audible Prompt/Feedback (2282)

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

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that the speaker was needed to be replaced.It is unknown if there was audio.It is unknown if the device was 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 the speaker was needed to be replaced.It is unknown if there was audio.It is unknown if the device was in use on a patient at the time of the reported issue.No death, or patient/user injury or harm was reported.

• Brand Name: SERIES 50A ANTEPARTUM FETAL MONITOR
• Type of Device: SERIES 50A ANTEPARTUM FETAL MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12550349
• MDR Text Key: 274076970
• Report Number: 9610816-2021-10372
• Device Sequence Number: 1
• Product Code: HFM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K921957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• 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: Health Professional
• Device Model Number: 862336
• Device Catalogue Number: 862336
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/03/2002
• 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