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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS AVALON FM30 FETAL MONITOR
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PHILIPS MEDICAL SYSTEMS AVALON FM30 FETAL MONITOR Back to Search Results
Model Number M2703A
Device Problem Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer reported bradycardia alarm did not alarm.No patient involvement.
 
Manufacturer Narrative
H10: during the course of the evaluation it turned out that a failure to alarm for bradycardia did not happen.The device worked as intended and there was no malfunction of the device.No further investigation or action is warranted.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
Event Description
The customer reported that the avalon fm30 did not alarm for bradycardia.The device was in use on a patient.There was no report of patient or user harm.
 
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Brand Name
AVALON FM30 FETAL MONITOR
Type of Device
FETAL MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
hewlett-packard str.2
boeblingen 71034
GM  71034
MDR Report Key10662312
MDR Text Key211865974
Report Number9610816-2020-00371
Device Sequence Number1
Product Code HGM
Combination Product (y/n)N
PMA/PMN Number
K052795
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 09/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM2703A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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