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 Respiratory Arrest (4461)

Event Date 09/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that a nurse (rn) went into patient room and patient not breathing on (b)(6) 2020 before 10:30 am.When asked if the philips information center ix (pic ix) alarmed, the customer was unsure but remarking that respiratory rate not the same at the bedside.The patient had to be resuscitated.

Manufacturer Narrative

A philips field service engineer (fse) spoke to the customer.The fse determined the customer was asking for clarification on the values being displayed for this issue; there was no indication of an alarm failure noted by the fse.There was no product malfunction; this is considered a user training issue.A philips clinical specialist (cs) was able to provide the information on the values, as requested by the customer.The device remains at the customer site.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: 10592677
• MDR Text Key: 208750420
• Report Number: 1218950-2020-05693
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: (01)00884838093041
• Combination Product (y/n): N
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

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: 09/17/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 88 YR