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

Model Number 866424

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 03/02/2018

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.Patient information has been requested.

Event Description

The customer called asking for assistance retrieving data for a patient that expired.

Manufacturer Narrative

No device malfunction occurred.Per communications with the fse, no evaluation of the device/system was performed.There was no allegation of a device malfunction.The customer was seeking to retrieve patient data only.The customer was informed that the patient would have to be re-admitted to an empty sector, but if done after 7 days, the information will no longer be available.According to the fse, the customer was not able to obtain the patient information for the file.

• Brand Name: PIIC IX HARDWARE
• Type of Device: CENTRAL STATION MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7385315
• MDR Text Key: 103952271
• Report Number: 1218950-2018-03026
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838048645
• UDI-Public: (01)00884838048645(10)B.02.12
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2018

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 03/30/2018
• Supplement Dates Manufacturer Received: 03/21/2018
• Supplement Dates FDA Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2018
• 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