MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP60

Model Number 862450

Device Problems Device Alarm System (1012); No Audible Alarm (1019)

Patient Problems Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2023

Event Type  Injury  

Manufacturer Narrative

Reporter phone number: (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 intellivue mp60 patient monitor did not generate a high priority red alarm for a low non-invasive blood pressure (nibp) of 44/17 mmhg on (b)(6) 2023.The device was in use monitoring a patient at the time of the reported issue.No death or patient injury or harm was reported.

Event Description

The customer reported that the intellivue mp60 patient monitor did not generate a high priority red alarm for a low invasive blood pressure (ibp) of 44/17 mmhg on 26-april-2023, resulting in the immediate need for adjustment in iv vasoactive medications.The device was in use monitoring a patient at the time of the reported event.A serious injury to the patient was reported.

Manufacturer Narrative

Philips has received a complaint on the intellivue mp60, indicating "at 16:37 on april 26, 2023, the monitor did not generate a high priority red alarm for a low invasive blood pressure (ibp) of 44/17 mmhg." the device was in clinical use during the event.The customer reached out to philips via a national medical products administration report (nmpa # (b)(4)) requesting an investigation of this issue.The nmpa reported that at16:37 on april 26, 2023, the patient's blood pressure was as low as 44/17mmhg, and the average pressure was 24mmhg.The monitor did not prompt a red alarm.The doctor was in the ward at the time and immediately administered vasoactive drugs, and the patient's blood pressure was normal 5 minutes later without consequences.No other clinical information or medical intervention was reported.A good faith effort (gfe) was conducted several times, but no further information if the device was tested or logs were reviewed and information regarding the alarm settings was provided.A philips field service engineer (fse) reached out to the customer, and confirmed that the event date was on april 26,2023, but philips never received any feedback on the issue at the time.The customer stated that this issue was about an invasive pressure alarm, and it only happened one time.The alarm was normal before and after the occurrence of the incident, and the customer added that since the incident happened on april 26, 2023, there were no valuable clues to support the investigation of the problem.Based on the information available, the cause of the reported problem remains unknown.The engineer couldn't provide any analysis findings because the customer did not respond to requests for additional information.It was confirmed the issue has not recurred, however, philips is unable to confirm the final disposition of the device.The investigation concludes that no further action is required.H3 other text : device not made available for evaluation.

• Brand Name: INTELLIVUE MP60
• Type of Device: INTELLIVUE MP60
• 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: 17709115
• MDR Text Key: 322926625
• Report Number: 9610816-2023-00451
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 862450
• Device Catalogue Number: 862450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2011
• 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): Required Intervention