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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS; DRT
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PHILIPS MEDICAL SYSTEMS; DRT Back to Search Results
Model Number M1646A
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer reported that a patient needed picco (pulse contour continuous cardiac output) monitoring.While the patient was being monitored, it was found that there was no signal due to the cables not working.It was reported that the picco transducer was not working and was re-seated three times, without success.The customer decided to put in a pulmonary artery catheter.It was futher reported that issues arose with the cables and the monitor again and that there was no signal from the pulsion device.The patient was reported to be without cardiac output monitoring for 4-7 hours, but there was no negative impact to the patient reported.
 
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Brand Name
NA
Type of Device
DRT
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
wendy chadbourne
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6756640
MDR Text Key81669873
Report Number1218950-2017-05139
Device Sequence Number1
Product Code DRT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K150310
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM1646A
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/29/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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