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

Model Number M8007A

Device Problems Disconnection (1171); Device Dislodged or Dislocated (2923)

Patient Problems Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Date 05/08/2015

Event Type  Injury  

Event Description

The ward has registered an event regarding a patient whose arterial blood pressure was being monitored.The nurse noticed that the abp wave was gone, the time for this was 09:40.When the nurse checked the patient, she found that the intra-arterial cannula was pulled out from the patient, with bleeding as a result.When the nurse reviewed the patient's data, the abp line disconnection seemed to have happened at about 09:13.Approximately 1/3 of the patient's blood volume was lost.The patient received blood transfusion and was discharged from the ward.

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.(b)(4).

Manufacturer Narrative

The investigation found no product malfunction.There is no allegation of malfunction as when the event trends were being reviewed, it was found that the staff had turned off the alarm.This is a use issue error which can negatively impact patients.The customer requested a feature which provides notification when a single alarm has been turned off.The customer was provided with a written response addressing their enhancement request and this has been forwarded to the product marketing staff as a suggested improvement.

• Brand Name: MP70 INTELLIVUE PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; böeblingen 71034 ; GM 71034
• Manufacturer Contact: wendy chadbourne ; hewlett-packard str.2; böeblingen 71034 ; GM 71034
• MDR Report Key: 4901277
• MDR Text Key: 6020623
• Report Number: 9610816-2015-00131
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: M8007A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2015
• Initial Date FDA Received: 07/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other