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

Model Number 866424

Device Problem Device Alarm System (1012)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/19/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that a patient coded when their sp02 alarm did not go off as expected.

Manufacturer Narrative

A philips clinical consultant (cc) contacted the customer.The cc found the issue to be a result of an end user error, and not related to configuration or equipment malfunction.The end user had shut off the spo2 alarms off days prior to the event and they were never turned back on.As a result, the patient event occurred resulting in a transfer to a higher level of care within the facility; the eventual outcome was not known.The spo2 alarms being shut off on this patient¿s monitor was identified via the clinical audit tool and confirmed with clinical engineering.There was no product malfunction; this was a user issue.As a result of the confirmed findings by the philips clinical consultant, it was determined that there was no need for any configuration changes.There were no concerns regarding equipment malfunction, and the monitoring equipment did function appropriately.The cc was informed that the matter would be managed internally at the facility, as they do have policies in place for prevention of this from occurring.We will consider that the customer resolved the issue and that the device remains in use at the customer site, as no subsequent calls have been logged for this device/issue.No further investigation or action is warranted at this time.

• 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: 8573017
• MDR Text Key: 143812796
• Report Number: 1218950-2019-03229
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2019

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 04/22/2019
• Supplement Dates FDA Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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): Life Threatening