MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP5

Model Number 865024

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2024

Event Type  Death  

Event Description

It was reported after the patient returned to the hospital ward after a c-section, the monitor did not display the pulse rate when the spo2 probe was applied to the finger but oxygen saturation was displayed.The probe was taken off and reapplied multiple times with no pulse rate displaying so the monitor was replaced, which displayed pulse rate and oxygen saturation.It was indicated this issue delayed postpartum vital signs monitoring.It was determined there was sensor damage and low perfusion due to low limb temperature and poor peripheral circulation secondary to intraoperative anesthesia and blood loss.Based on this information, device malfunction and the post-surgical patient condition resulted in a delay in care.A patient death was reported.The device was in use on a patient.There was a report of patient or user harm.

Manufacturer Narrative

E1: reporter institution phone number: (b)(6).A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported after the patient returned to the hospital ward after a c-section, the monitor did not display the pulse rate when the spo2 probe was applied to the finger, but oxygen saturation was displayed.The probe was taken off and reapplied multiple times with no pulse rate displaying so the monitor was replaced, which displayed pulse rate and oxygen saturation.It was indicated this issue delayed postpartum vital signs monitoring.Additional information was requested and it turned out that a 5-minute delay did not lead to any harm for the patient and the customer refused to disclose the patient's current condition.The patient's pulse could be manually palpated.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

An onsite evaluation was performed, and it turned out, that the reported issue was caused by a defective spo2 sensor.Philips requested further relevant information whether a philips spo2 sensor or a third party spo2 sensor was used, but none was provided.Based on the information available, the cause of the reported problem was a defective spo2 sensor.The reported problem was confirmed.The customer replaced the spo2 sensor to resolve the issue.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIVUE MP5
• Type of Device: INTELLIVUE MP5
• 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: 18825253
• MDR Text Key: 336743446
• Report Number: 9610816-2024-00117
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000230
• UDI-Public: 00884838000230
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K150310
• 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: 865024
• Device Catalogue Number: 865024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death