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

Model Number 866424

Device Problem No Audible Alarm (1019)

Patient Problem Loss Of Pulse (2562)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that central station (pic ix) failed to alarm on (b)(6) 2019 at 13.05; the patient went into a p-wave asystole.T is unclear at the time of this report, if there was a patient injury.However, if a patient enters asystole this represents a life threatening condition.

Manufacturer Narrative

H10: a philips field service engineer (fse) went to the customer site.The fse checked the alarm with a patient simulator while, and the device alarmed as expected.The fse obtained the alarm log from the pic ix, and images of the general review screen.The general review screen images show that red alarms occurred for asystole: the alarm log was sent to a philips complaint investigator (ci) for review.The ci found that alarms were silenced at 13:04:09; alarms will not occur, until after the configured alarm delay.The default setting of the alarm delay is three minutes, and as seen in the alarm log, after three minutes, the device began to alarm at 13:07:02 for a ecg leads off: based on the investigation, there was no product malfunction; the alarms had been silenced at 13:04 for an asystole alarm occurring at 13:00, and the reported asystole alarm at 13:05 was within the alarm delay window.The device remains in use at the customer site.No subsequent calls have been logged for this device/issue.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: 9186190
• MDR Text Key: 162784111
• Report Number: 1218950-2019-07785
• 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: 10/11/2019

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 10/11/2019
• Supplement Dates FDA Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening