MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE INFORMATION CENTER IX; CENTRAL STATION MONITOR

Model Number 866389

Device Problem Device Alarm System (1012)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/26/2020

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

The customer reported that on (b)(6) 2020, a patient in bed t2087 had to be resuscitated due to missing alarms.According to the customer's colleagues, there were no alarms and oxygen saturation was not noticed.

Manufacturer Narrative

H10: a philips remote service engineer (rse) was in contact with the customer biomedical engineer (biomed), and obtained alarm audit logs from the philips information center ix (picx ix).The rse reviewed alarm log data around that time.The rse informed the biomed that the audit logs on (b)(6) 2020 14:50:35 show the technical alarm of a dropped spo2 sensor, which is visually identified in the sector and also with a tone for a technical alarm.The sound output at the central office could possibly have been overwritten by an alarm from another bed with a higher alarm priority, but this does not change the representation in the sector.The alarms (spo2 sensor off, ** nbps 77 <100) of the bed t2087 were acknowledged at (b)(6) 2020 15:02:05 at the control center.The condition of the dropped spo2 sensor was only corrected after the questioned time on (b)(6) 2020 15:15:24 at the bedside monitor.Due to the dropped sensor, no alarms regarding the saturation could be issued.The sensor drop was alarmed and acknowledged at the control center about 12 minutes later, and fixed again on the bed side about 13 minutes later.No technical malfunction of the monitor or the pic ix is evident with the information available.There was no product malfunction.Due to the dropped sensor, no alarms regarding the saturation could be issued.This is a user issue.The investigation results were provided to the customer.No further investigation or action is warranted at this time.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: INTELLIVUE INFORMATION CENTER IX
• Type of Device: CENTRAL STATION MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9774384
• MDR Text Key: 181558958
• Report Number: 1218950-2020-01359
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838086715
• UDI-Public: (01)00884838086715
• Combination Product (y/n): N
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

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: 866389
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 02/27/2020
• Supplement Dates FDA Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 55 YR
• Patient Weight: 86