MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MUTLI MEASUREMENT SERVER (MMS); COMPACT PATIENT MONITOR

Model Number M3001A

Device Problem Deflation Problem (1149)

Patient Problem No Code Available (3191)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported on (b)(6) 2019 they were measuring non-invasive blood pressure (nibp) using an intellivue measurement server (mms).The nibp pump never deflated, causing the patient to lose circulation in the arm that the nibp was being measured on.Intervention occurred for blood circulation to be fully restored.

Manufacturer Narrative

A philips remote service engineer (rse) spoke with the customer biomed who tested the mms module on a 15-minute interval and was not able to replicate the reported issue.The biomed reported to the rse the end user is using philips nibp hoses with welch allyn cuffs.The biomed declined a philips field service engineer (fse) onsite visit, as the biomed had philips monitoring training and does not believe the issue is equipment related, as some alarms that were silenced were not addressed properly by the end user.The rse followed-up with the biomed who pulled all equipment, performed testing and released the equipment back into clinical use.Although philips cannot rule out a product malfunction, the customer biomed was not able to reproduce the reported failure and determined the cause to be the end user not being educated on the alarms, and not addressing them properly.: patient information requested, information not available.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: INTELLIVUE MUTLI MEASUREMENT SERVER (MMS)
• Type of Device: COMPACT PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 9289604
• MDR Text Key: 165396673
• Report Number: 9610816-2019-00296
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K030038
• 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: 10/16/2019

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: M3001A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/07/2019
• Supplement Dates Manufacturer Received: 10/16/2019
• Supplement Dates FDA Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention