MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLISPACE PERINATAL K LARGE ARCH.

Model Number 867061

Device Problem Defective Alarm (1014)

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

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

The remote service engineer (rse) spoke with the customer, and the customer advised that the staff can now hear the alarms, so no support was needed for alarms.A good faith effort (gfe) was performed to determine the cause of the issue and how the customer resolved the issue, but no additional information was provided.The customer advised that the device was operational.If additional information is received the complaint file will be reopened.

Event Description

It was reported that the system is not alarming.The device was in use at time of event, there was no adverse event reported.

• Brand Name: INTELLISPACE PERINATAL K LARGE ARCH.
• Type of Device: INTELLISPACE PERINATAL K LARGE ARCH.
• 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 ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 17826251
• MDR Text Key: 324377069
• Report Number: 9610816-2023-00483
• Device Sequence Number: 1
• Product Code: HGM
• UDI-Device Identifier: 00884838084483
• UDI-Public: 00884838084483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173941
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 867061
• Device Catalogue Number: 867061
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2021
• 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