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U.S. Department of Health and Human Services

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

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PHILIPS MEDICAL SYSTEMS MP70 INTELLIVUE PATIENT MONITOR Back to Search Results
Model Number M8007A
Device Problem No Audible Alarm (1019)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 03/09/2020
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

The customer reported that no audible alarm for the invasive blood pressure (ibp) measurement. Was announced for the patient in its2 bed 14 on (b)(6) 2020 at 21:52. This caused bleeding because it was not noticed immediately due to the lack of the alarm. The device was in use monitoring a (b)(6)-year old male patient at the time of the reported event. Due to the alleged failure to generate an audible alarm, the patient was bleeding which was not noticed immediately.

 
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Brand NameMP70 INTELLIVUE PATIENT MONITOR
Type of DevicePATIENT MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
hewlett-packard str.2
boeblingen 71034
GM 71034
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
betty harris
hewlett-packard str.2
boeblingen 71034
GM   71034
MDR Report Key9852958
MDR Text Key184067505
Report Number9610816-2020-00097
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK021300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 03/11/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM8007A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/11/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/07/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 03/19/2020 Patient Sequence Number: 1
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