MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PIIC IX HARDWARE; CENTRAL STATION MONITOR

Model Number 866424

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 05/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer requested assistance with the retrieval of data at their philips intellivue information center (piic).There is mention of a cardiac event / accident.Additional information has been requested to clarify this.

Event Description

The customer requested assistance with the retrieval of data at their philips intellivue information center (piic).There is mention of a cardiac event / accident.

Manufacturer Narrative

H10:a philips remote support engineer (rse) reviewed the procedure to follow to access the patient¿s data, as their discharge had already been performed.It was noted that the customer wished to be able to extract the data in an electronic format, as only the generation of paper reports was functional.Rse provided the contact details for a philips sales engineer for an upgrade request for this functionality.The rse indicated there was no malfunction of the piic.The customer was calling for application support.The piic did not cause or contribute to the cardiac event.The device remains in use at the customer¿s site.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: PIIC IX HARDWARE
• Type of Device: CENTRAL STATION MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10055530
• MDR Text Key: 190900866
• Report Number: 1218950-2020-02813
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838052130
• UDI-Public: (01)00884838052130
• 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: 05/04/2020

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: 866424
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/14/2020
• Supplement Dates Manufacturer Received: 05/04/2020
• Supplement Dates FDA Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening