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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Skin Irritation (2076); Skin Inflammation (2443); Skin Tears (2516)

Event Date 09/01/2019

Event Type  malfunction  

Event Description

Zoll defib pads causing skin integrity issues when removed 24-hours post-op.Multiple patients impacted.Variety of integrity issues noted ¿ ranging from blistering skin, to redness and irritation to skin tears.

• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 9219920
• MDR Text Key: 163295653
• Report Number: 9219920
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other