MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH EFFICIA CM12

Model Number 863311

Device Problem Incorrect Measurement (1383)

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

Event Date 12/28/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information regarding the reported event and the investigation is ongoing.A follow-up report will be submitted upon completion of the investigation.(b)(6).

Event Description

The customer reported that abnormal spo2 values displayed from the device.The device was in use at time of event, there was no adverse event reported.

Manufacturer Narrative

The philips authorized service provider (asp) went for onsite service for further investigation of the device and it was found that the spo2 sensor was defective and results of functional testing indicate the spo2 sensor had malfunction.The device was operational after spo2 sensor was replaced.A gfe was performed to find out more details.The customer didn't know whether the defective spo2 sensor was from philips or not.No part number was provided from the customer.

Manufacturer Narrative

The device was evaluated by the hospital 3rd party went for service for further investigation of the device and it was found that the spo2 sensor was defective and results of functional testing indicate the spo2 sensor had malfunction.The device was operational after spo2 sensor was replaced.A gfe was performed to find out more details.The customer didn't know whether the defective spo2 sensor was from philips or not.No part number was provided from the customer.

• Brand Name: EFFICIA CM12
• Type of Device: EFFICIA CM12
• 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: 18668396
• MDR Text Key: 335318810
• Report Number: 9610816-2024-00064
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,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: 863311
• Device Catalogue Number: 863311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 02/22/2024; 02/22/2024
• Supplement Dates FDA Received: 03/12/2024; 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• 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