MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PATIENT INFORMATION CENTER IX

Model Number 866389

Device Problem Defective Alarm (1014)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2024

Event Type  Death  

Event Description

It was reported spo2 alarm was not generated for this med-surg patient and they were transferred to icu, where they remained unresponsive.The patient's condition was poor prior to the event and they were being monitored for oxygen saturation.The nursing staff was alerted to the change in patient condition visually at the central station.The type of intervention and current status of the patient remain unknown.The customer requested assistance in determining whether the system was working correctly.

Manufacturer Narrative

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.

Manufacturer Narrative

Philips received a complaint on the patient information center ix indicating that on march 8th, 2024, the system did not alarm for bed 123a when the patient saturation dropped.The patient was transferred to the icu, where they remained unresponsive.The patient did not pass away but is on life support.The following functional tests were performed: a field service engineer (fse) went onsite and pulled the error logs and clinical audit logs.The fse checked the current status of the piic and found that it was working properly.The complaint was escalated for technical investigation, and a clinical product specialist reviewed the clinical audit log.The log shows many low spo2 alarms starting on march 7th, 2024, at 20:05.On march 8th, 2024, at 00:30, there was an a spo2 low alarm for a value of 83, which was then acknowledged.Then, on march 8th, 2024, at 01:46, there are alarms for low spo2, ¿desat¿, low hr, and ¿non-sustain vt¿ that were discarded by the user.At 02:37, the logs note that there was a silence action performed at the pic ix for this bed, but there is no evidence of what alarm was silenced.However, it is presumed that there was a cyan inop that was not logged in the audit logs.The version of pic ix (b.02.06) does not log every single inop.The log includes all severe (yellow or red) inops, all battery inops, ¿ecg leads off¿, ¿transmitter off¿, ¿no spo2t¿, and ¿batt low¿.At 02:40, additional alarms for low spo2 and ¿desat¿ are logged and were silenced by the user.Based on the information available, there was no product malfunction found with the device, as the device alarmed for low spo2 and ¿desat¿, and there was a silencing of these alarms by the user.The reported problem was not confirmed.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: PATIENT INFORMATION CENTER IX
• Type of Device: PATIENT INFORMATION CENTER IX
• 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: 19030419
• MDR Text Key: 339204599
• Report Number: 1218950-2024-00231
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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?: No
• Device Operator: Health Professional
• Device Model Number: 866389
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2017
• 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