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

Model Number 862336

Device Problem Defective Alarm (1014)

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

Event Date 12/27/2022

Event Type  malfunction  

Event Description

The customer reported that the alarms do not work.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.

Manufacturer Narrative

Reporting institution phone #: (b)(6).Reporter phone #: (b)(6).A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported that the alarms do not work.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.A philips remote service engineer (rse) provided a technical investigation.The rse confirmed the customer's alleged malfunction.The rse informed the customer the monitor had been obsolete since (b)(6) 2012.The rse assigned a philips field service engineer (fse) to the case to see if it the unit could be repaired.The fse reported the equipment to be out of its serviceable period and it was not possible to repair the equipment.No further information was provided.

• 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: hauke schik ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16193595
• MDR Text Key: 307560207
• Report Number: 9610816-2023-00003
• Device Sequence Number: 1
• Product Code: HFM
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• 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
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1