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

Model Number PROPAQ 242

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Fluid/Blood Leak (1250); Hole In Material (1293); Melted (1385); Arcing (2583); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2016

Event Type  malfunction  

Event Description

Propaq monitor failed to power up when used.During evaluation, it was noticed that there was hole burned through the top of the machine above the battery compartment.The hole was about 1cm across.Based on the degree of charring, it is evident there was a flame present at some point.Luckily the fire did not spread and self-extinguished.Further investigation showed the battery was extremely swollen, melted, and leaking acid.The fuse board that attaches to the battery had failed and started arcing, causing the fire.The battery was about 4 years old and supplied by unipower.The transport monitor was deemed uneconomical to repair and has been discarded.

• Brand Name: PROPAQ
• Type of Device: MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
• Manufacturer (Section D): WELCH ALLYN INC; 4341 state street road; skaneateles falls NY 13153
• MDR Report Key: 5658727
• MDR Text Key: 45290353
• Report Number: 5658727
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PROPAQ 242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2016
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1