MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP70 INTELLIVUE PATIENT MONITOR

Model Number M8007A

Device Problem Alarm Not Visible (1022)

Patient Problem No Code Available (3191)

Event Date 07/14/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that no alarms were generated.Patient treatment was required.

Manufacturer Narrative

H3 and h6: the customer did not want to have a philips field service engineer at the customer site for onsite service, they wanted to get help to full the data.No report that equipment not functioning correctly at this time.The customers biometrical engineer pulled back-up error logs from classic piic.The alarm log from the piic was sent to philips for further investigation and was reviewed by the remote application specialist.It was found that the alarm files showing multiple alarms with sound on 14july-2019 for desat and apnea between 17:44 through 23:57 hours.At 17:44:14 that a desat alarm had occurred with sound; this alarm was silenced at 17:47:31.Other red alarms were also seen to have occurred through 23:57, and the alarms had been silenced.The fse asked the nurse if they noticed anything abnormal with the monitor and they said no.The nurse manager stated that they think this is the user issue and not the monitor.They are planning to have education for all the staff/nurses.There was no product malfunction; this was determined to be a user issue.The device remains at the customer site.No further investigation 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: MP70 INTELLIVUE PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 8845003
• MDR Text Key: 152750845
• Report Number: 9610816-2019-00195
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K021300
• 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: 07/16/2019

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: M8007A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 07/31/2019
• Supplement Dates Manufacturer Received: 07/16/2019
• Supplement Dates FDA Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 55