MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP50

Model Number 862116

Device Problem Device Alarm System (1012)

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

Event Date 02/03/2023

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported that due to changing high/low limits on arterial lines to values incompatible with life, no realarm was triggered for a patient and it caused an unspecified serious injury.

Event Description

Philips received a complaint on the intellivue mp50 indicating that there was concern that staff have the ability to change the high and low limits for invasive blood pressure to values incompatible with life (systolic high of 360 mmhg and low -40 mmhg).It has been requested that there be a lock out numerical value.It was reported that a serious patient outcome occurred as a result of placing the high/low values to the max limits, and no red alarm was triggered.No further details regarding the patient harm were provided, and the patient outcome is unknown.

Manufacturer Narrative

The product support engineer (pse) analyzed the enhancement request and provided the below summary: the alarm limits must be configurable over the whole measurement range (-40 to 360 mmhg) per the international standard iec 60601-2-34 in subclause 208.6.6.2.101.Philips equipment is compatible to this standard.The request for a lock out numerical value cannot be fulfilled, as philips must follow the international standard.However, the enhancement request has been documented for consideration, so that the product experts can decide on what is fulfilling the international standard iec 60601-2-34 in subclause 208.6.6.2.101 demands and what is helping the customer/user for such cases.Based on the information available and the testing conducted, the cause of the reported problem was the user, as the staff changed the high and low values to the max limits.The monitor functioned as intended.The reported problem was confirmed.The customer adjusted the abp/art settings to resolve their issue.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIVUE MP50
• Type of Device: INTELLIVUE MP50
• 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: 16461889
• MDR Text Key: 310452108
• Report Number: 9610816-2023-00104
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K151681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 862116
• Device Catalogue Number: 862116
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2023
• 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): Other