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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PIIC IX HARDWARE; CENTRAL STATION MONITOR
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PHILIPS MEDICAL SYSTEMS PIIC IX HARDWARE; CENTRAL STATION MONITOR Back to Search Results
Model Number 866424
Device Problems Device Alarm System (1012); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event Description
The customer reported that a patient was monitored with telemetry and had a gap in monitoring which they presumed represented an asystole event however no asystole alarm was provided.It was confirmed that no patient harm occurred.This was a long pause event and not a patient code event.No emergent care was warranted.
 
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Brand Name
PIIC IX HARDWARE
Type of Device
CENTRAL STATION MONITOR
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 Key7938641
MDR Text Key123067264
Report Number1218950-2018-07884
Device Sequence Number0
Product Code MHX
Reporter Country CodeSW
PMA/PMN Number
K102495
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 09/19/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number866424
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/19/2018
Initial Date FDA Received10/05/2018
Supplement Dates Manufacturer Received09/19/2018
Supplement Dates FDA Received09/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/28/2016
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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