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

Model Number 862451

Device Problem Defective Alarm (1014)

Patient Problems Hypoxia (1918); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2023

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted after philips obtains more information concerning this event.E1: reporting address state: (b)(6).

Event Description

It was reported the customer requested an assessment to determine where a desaturation alarm was silenced/acknowledged.Subsequently the patient required the rapid response team due to desaturation.The record indicates patient harm, but further information about the harm is not provided.

Manufacturer Narrative

A philips technical consultant (tc) went onsite to evaluate the device in question.Per the tc, there was no patient injury, as the staff were able to assist before the patient was injured.The tc checked the alarms of the patient room by running a demo and electrical safety tests.The tc confirmed the following: the unit was operating in solo mode at the time of the event; on (b)(6), the alarms had been shut off by nursing staff; on (b)(6) 2023, at approximately 1700 the patient had a desaturation event, but there was no alarm.Initially, the tc thought the alarm had been silenced at the bedside, but then realized that the alarm was disabled.The patient desaturated to 50% and there was a delay in recognition by monitor technicians and nursing staff because, once again, the alarm had been disabled.The customer provided the clinical audit logs to be evaluated by the philips product support engineer (pse).The tc determined there was no issue found with the monitor.The philips pse confirmed there was a desaturation alarm generated at 17:09.The customer acknowledged the alarm shown on the overview at 17:09:44.The pse reported other alarms were being played until there was another acknowledgement at 17:12:45 on the (b)(6) bedside.Then at 17:12:50, there was a reminder of the red alarm until it was paused at 17:12:54.On the pic stations 3sover1 and pcusrv, the desaturation alarm was played.They didn¿t hear it on the bedside until 17:15:59 when the alarms were resumed; they heard the alarms on the bedside at that time.The pse identified this situation as a user issue and not a device issue.Based on the information available, and the logs provided by the customer, the cause of the reported problem was confirmed to be nurses turning off spo2 alarms on monitor and the workflow.The alarms were visible on the clinical logs.Based on the information available and results of additional analysis, no further action is necessary at this time.The nursing manager has corrected the workflow by adjusting the oxygen and correction of alarms to prevent future issues.The patient was discharged a few days later without issue.The device remains at the customer site.No further investigation or action is warranted at this time.

• 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: 17787560
• MDR Text Key: 323899752
• Report Number: 9610816-2023-00473
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 862451
• Device Catalogue Number: 862451
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/21/2023
• Supplement Dates Manufacturer Received: 10/18/2023; 10/18/2023
• Supplement Dates FDA Received: 11/08/2023; 11/29/2023
• 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): Required Intervention; Life Threatening
• Patient Age: 65 YR
• Patient Sex: Male