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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP5

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PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP5 Back to Search Results
Model Number 865024
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2021
Event Type  Malfunction  
Event Description

The customer called philips to report the following: "feedback we receive from the northwest women and children's hospital, when a link m1133a one-time blood oxygen probe (no link to the patient's body), the value of blood oxygen, perfusion value, pulse, numerical display, alarm thresholds are within the normal range, this case is 5-10 minutes, and without any alarm equipment, if the patient in an emergency situation, will seriously delay for the treatment of patients with time, and even death in patients, hospital requirements to solve this problem as soon as possible. The device was reported to be in use on a patient, but no adverse event to patient or user was reported.

 
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Brand NameINTELLIVUE MP5
Type of DeviceINTELLIVUE MP5
Manufacturer (Section D)
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM 71034
Manufacturer (Section G)
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM 71034
Manufacturer Contact
derek sammarco
222 jacobs street
cambridge, MA 02141
MDR Report Key11543818
MDR Text Key242726490
Report Number9610816-2021-10038
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK150310
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/22/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number865024
Device Catalogue Number865024
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date03/05/2021
Event Location No Information
Date Manufacturer Received03/05/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/08/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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