MAUDE Adverse Event Report: ZOLL MEDICAL CORP. PROPADZ; AUTOMATED EXTERNAL DEFIBRILLATOR (NON-WEARABLE)

Model Number R SERIES ALS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 02/03/2021

Event Type  No Answer Provided  

Event Description

Patient sustained superficial burns to chest after use of propadz and was treated with antibiotics.Reporter states the device has been pulled out of service for further investigation to err on the side of caution and that there is a possible propadz placement error during use.

• Brand Name: PROPADZ
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORP.
• MDR Report Key: 11286274
• MDR Text Key: 230793036
• Report Number: MW5099256
• Device Sequence Number: 1
• Product Code: KXF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/04/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: R SERIES ALS
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR