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

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.

• 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 Key: 3783288
• MDR Text Key: 4359475
• Report Number: 3783288
• Device Sequence Number: 1
• Product Code: DRT
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Number: 242
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2014
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANY BATTERY COMPANY'S BATTERY.