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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS 5 LEAD SET SNAP AAMI, ICU; ECG LEAD SET
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PHILIPS MEDICAL SYSTEMS 5 LEAD SET SNAP AAMI, ICU; ECG LEAD SET Back to Search Results
Model Number M1644A
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
An ecg leads related issue could prevent demand mode pacing or delay therapy/treatment.We are still in the process of assessing if there's a risk to health.This complaint is being reported in order to meet the reporting deadlines.A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer reported a leads off error while using the 989803176161, ecg lead set.The customer did not report any patient/user involvement.
 
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Brand Name
5 LEAD SET SNAP AAMI, ICU
Type of Device
ECG LEAD SET
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
wendy chadbourne
3000 minuteman road
andover, MA 01810
MDR Report Key5238760
MDR Text Key32024115
Report Number1218950-2015-06313
Device Sequence Number1
Product Code DSA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020531
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM1644A
Device Lot Number2013-09
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/09/2015
Was Device Evaluated by Manufacturer? Yes
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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