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

Model Number M3001A

Device Problems No Audible Alarm (1019); Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer called philips to report that following an arterial line (ibp) disconnect, no audible alarm was heard from the bedside or central station.Following a chest x-ray, a nurse found the patient's arterial line (ibp) tubing accidentally disconnected from the catheter and leaking, with blood on the floor underneath the patient.The nurse reconnected the tubing and sedated the patient, but the customer has reported that no additional medical intervention was required.The customer has also reported no lack of awareness of the patient's condition, no delay of care, and no deterioration of the patient's condition.

Manufacturer Narrative

H3 and h6 : a philips field service engineer (fse) visited the customer site and collected alarm audit logs from the philips intellivue information center (piic) containing the date/time of the event.Philips was unable to collect and has not been provided with any screen shots or logs from the associated mp70 for review.In a good faith effort conference call on (b)(6)2020, the customer's staff reported that that the multimeasurement server (mms) and the associated mp70 bedside monitor were both performance tested by the biomedical staff and confirmed to be operational.The customer's staff also reported that the mms and the associated mp70 bedside monitor remain in clinical use on patients.There is insufficient data available to philips for philips to identify the cause for the mms and the associated mp70 not alarming.An ¿ibp/abp disconnect¿ red alarm was not recorded in the alarm audit log provided, but pressure may have remained in the arterial line, possibly causing the alarm criteria not to have been met.An ¿ibp/abp no pulse¿ red alarm was not recorded in the alarm audit log, but it remains unknown to philips if the inop was configured as a red (or yellow) alarm and if the alarm criteria had been met.The customer's staff confirmed that the mms and mp70 were functioning as intended and that the devices have remained in clinical use on patients.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: 10263180
• MDR Text Key: 198487100
• Report Number: 9610816-2020-00232
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• 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
• Date Manufacturer Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR
• Patient Weight: 103