MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL DEFIBRILATOR PADS; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 0004985

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Abrasion (1689)

Event Date 06/28/2019

Event Type  malfunction  

Event Description

Device caused skin tear/abrasion to chest.

• Brand Name: ZOLL DEFIBRILATOR PADS
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 9117317
• MDR Text Key: 160021307
• Report Number: 9117317
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/31/2019,07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0004985
• Device Catalogue Number: 0004985
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other