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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS CABLE ECG 6 LEAD; DSI
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PHILIPS MEDICAL SYSTEMS CABLE ECG 6 LEAD; DSI Back to Search Results
Model Number 989803171961
Device Problems Loose or Intermittent Connection (1371); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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 requested information as to why the st analysis would fail.The record indicates the customer noted waveform gaps and that "no technical alarms for that the electrode come loose or the telemetry unit has lost contact." the device was in use on a patient.There was no report of patient or user harm.
 
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Brand Name
CABLE ECG 6 LEAD
Type of Device
DSI
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key8765906
MDR Text Key150378479
Report Number1218950-2019-04882
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K152330
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number989803171961
Device Catalogue Number989803171961
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2019
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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