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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM GAS-MACHINE, ANESTHESIA

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PHILIPS MEDICAL SYSTEMS COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM GAS-MACHINE, ANESTHESIA Back to Search Results
Model Number 866334
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer alleged, odd vitals in 4 or's. The device was reported to be in use on a patient, but no adverse event to patient or user was reported.
 
Manufacturer Narrative
The customer noted that the issue had been resolved.
 
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Brand NameCOMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM
Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
betty harris
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key10627396
MDR Text Key211510618
Report Number1218950-2020-05843
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number866334
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 Received09/15/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/02/2013
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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