MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP70

Model Number 862451

Device Problem Device Alarm System (1012)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2023

Event Type  Injury  

Manufacturer Narrative

(b)(6).Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

The customer reported that the alarms from the intellivue mp70 patient monitor were not recognized and a patient was harmed.No additional information regarding the adverse event was provided.The device was in use monitoring a patient at the time of the reported event.

Manufacturer Narrative

Philips received a complaint on the intellivue mp70 indicating that the alarms were not recognized, and the patient came to harm.No additional information regarding the adverse event was provided.The following functional tests were performed: the remote service engineer (rse) reached out to the customer for more information, and the customer advised that this case was opened mistakenly.The customer stated that the case was not due to a device defect, and the device worked properly.Based on the information available and the testing conducted, the cause of the reported problem is unknown.The reported problem was not confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.Due to the lack of available information, the exact cause for the reported issue remains unknown.The customer advised that the case was not due to a device defect, and the device is working properly.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.H3 other text : customer reported that the complaint was opened in error and there was no malfunction of the device.

• Brand Name: INTELLIVUE MP70
• Type of Device: INTELLIVUE MP70
• 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: 18192867
• MDR Text Key: 328813826
• Report Number: 9610816-2023-00619
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151681
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 862451
• Device Catalogue Number: 862451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 01/18/2024
• 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
• Patient Outcome(s): Other