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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RF TECHNOLOGIES, INC SAFE PLACE; MONITOR, BED PATIENT
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RF TECHNOLOGIES, INC SAFE PLACE; MONITOR, BED PATIENT Back to Search Results
Lot Number ML722132
Device Problems Defective Alarm (1014); Product Quality Problem (1506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/22/2022
Event Type  malfunction  
Event Description
Infant security system manufactured by rf technologies has had multiple instances of failure.Bands have either alarmed when on the patients or not alarmed when they have been cut off the patient.Vendor reports that it is a known issue with the soft bands yet still marketed this product as functional.After reporting events to vendor, it was reported that these types of malfunctions were known to occur with the soft bands supplied by the vendor and they are looking for a new supplier of soft bands to provide to us.We are now having to use the hard/inflexible bands that have more of a risk of causing discomfort or risk of pain to the infant.
 
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Brand Name
SAFE PLACE
Type of Device
MONITOR, BED PATIENT
Manufacturer (Section D)
RF TECHNOLOGIES, INC
3125 n 126th st
brookfield WI 53005
MDR Report Key14929597
MDR Text Key295343269
Report Number14929597
Device Sequence Number1
Product Code KMI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot NumberML722132
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/25/2022
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer07/06/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/06/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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