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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WELCH ALLYN PROTOCOL INC. PROPAQ CS; MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)

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WELCH ALLYN PROTOCOL INC. PROPAQ CS; MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) Back to Search Results
Model Number 242
Device Problems Overheating of Device (1437); Material Separation (1562); Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 01/14/2014
Event Type  malfunction  
Event Description
Physiologic monitor failed to operate.Upon troubleshooting, it was found that the battery was overheated to the point the seams on the battery started to separate, but no fluid or battery residue leaked from the batteries.Monitor no longer used at this facility, although this will be the second unit over several years that has failed due to excessive heat or malfunction of charging circuitry.
 
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Brand Name
PROPAQ CS
Type of Device
MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
Manufacturer (Section D)
WELCH ALLYN PROTOCOL INC.
4341 state street road
skaneateles falls NY 13153
MDR Report Key3783288
MDR Text Key4359475
Report Number3783288
Device Sequence Number1
Product Code DRT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 04/30/2014
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 Operator Invalid Data
Device Model Number242
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/30/2014
Device Age10 YR
Event Location Hospital
Date Report to Manufacturer05/01/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/30/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ANY BATTERY COMPANY'S BATTERY.
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