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

Model Number 866389

Device Problem Alarm Not Visible (1022)

Patient Problem Anaphylactic Shock (1703)

Event Date 07/05/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported intermittent data transmission disturbances that resulted in a failure to alarm for a patient experiencing anaphylactic shock on (b)(6) 2020 at 16:45.

Manufacturer Narrative

H3 and h6: an authorized philips field service engineer (fse) was at the customer site.Alarm log files were reviewed for the patient, who was located in bed "r.6a".It was found that the monitor for this bed (monitor 2) lost the connection to the central one at 20:32 on (b)(6) 2020, and only connected again on (b)(6) 2020 at 8:35; therefore, there was no central monitoring during the patient event.Alert / date / time bed / label action device name on (b)(6) 2020, 20:32; r.6a; device is offline; monitor2.On (b)(6) 2020, 8:35; r.6a; device is online; monitor2.The fse was able to verify that there was never any lack of awareness of the patient¿s condition or any delay in treatment; therefore, the event is not considered a serious injury.The fse installed the latest software both at the philips information center ix (pic ix) and on the monitors.In addition, the customer has ordered a new network switch, because it is suspected that the issue is due to a defective network switch.The reported malfunction was confirmed; there was an issue with data transmission, causing the affected bed to lose connection prior to the patient incident, and not being restored until after the incident.It was suspected that the network switch was defective.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.

Manufacturer Narrative

H6: the serious injury was not a result of the philips device, therefore, the event is not considered a serious injury.The cause of the central station drop out was due to the network switch.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: 10258807
• MDR Text Key: 198423240
• Report Number: 1218950-2020-03997
• Device Sequence Number: 1
• Product Code: MHX
• 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,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2020

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: 07/09/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 07/09/2020; 07/09/2020
• Supplement Dates FDA Received: 09/10/2020; 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 77 YR
• Patient Weight: 85