MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX800 PATIENT MONITOR

Model Number 865240 (MX800)

Device Problem Communication or Transmission Problem (2896)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 01/15/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that on (b)(6) 2019, the x2 module would not communicate with the mx800 monitor, during a patient code; the mx800 was asking for a password that no one had.The patient was coding.

Manufacturer Narrative

H3 and h6: the biomedical engineer reported that the mx800 asked for a password during a patient code.Although the biomed confirmed that the monitor did not cause or contribute to the reported patient code, it was a nuisance having to provide a password during the event.Despite numerous attempts to obtain additional information regarding the type of password requested and the resolution to the reported issue, no further details were provided.Based on the information provided, the exact cause for the reported issue could not be established.No further calls were received from the customer regarding the reported device and issue.Based on the information provided, the exact cause for the reported issue could not be established and a malfunction of the device cannot be ruled out.The available information from this report does not support that this failure represents a systemic, design, or labeling problem.No further investigation or action is warranted.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 MX800 PATIENT MONITOR
• Type of Device: INTELLIVUE MX800 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 8319711
• MDR Text Key: 135498706
• Report Number: 9610816-2019-00039
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K102562
• 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: 01/15/2019

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: 865240 (MX800)
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 01/15/2019
• Supplement Dates FDA Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR