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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS CBL 3 LEAD ECG TRUNK, AAMI/IEC 2.7M; TRUNK CABLE
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PHILIPS MEDICAL SYSTEMS CBL 3 LEAD ECG TRUNK, AAMI/IEC 2.7M; TRUNK CABLE Back to Search Results
Model Number M1669A
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Erythema (1840)
Event Type  malfunction  
Manufacturer Narrative
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 deteriorated m1669a trunk cable caused a red area on the patient's back.Emergent care was not required for the patient.
 
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Brand Name
CBL 3 LEAD ECG TRUNK, AAMI/IEC 2.7M
Type of Device
TRUNK CABLE
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
wendy chadbourne
3000 minuteman road
andover, MA 01810
MDR Report Key5534506
MDR Text Key41479379
Report Number1218950-2016-01896
Device Sequence Number1
Product Code DSA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K020531
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 03/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM1669A
Device Lot Number1B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/22/2016
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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