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

Model Number 8900-0225-01

Device Problem Device Slipped (1584)

Patient Problem Skin Tears (2516)

Event Date 09/07/2022

Event Type  malfunction  

Event Description

Patient experienced a cardiopulmonary arrest on davenport 8 and zoll cpr pads were placed.The patient was transferred to the icu for post cardiac arrest care.While in icu, patient experienced another cardiopulmonary arrest.During resuscitation efforts in the icu, the team found that the cpr pads were sliding during chest compressions and created a skin tear.Patient's skin was not wet/diaphoretic during resuscitation efforts.Patient did not regain and pulse and is now deceased.While doing post-mortem care, the primary rn and stat nurse saw extent of the skin tear located in the middle of the patient's sternum where chest compressions are performed.Staff also stated that this is not the first time they've seen a skin tear/abrasion from the cpr pads during chest compression on a patient with dry skin.

• Brand Name: ONESTEP CPR AA
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 15484658
• MDR Text Key: 300566268
• Report Number: 15484658
• 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: 09/20/2022

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 Model Number: 8900-0225-01
• Device Catalogue Number: 8900022501
• Device Lot Number: 3222
• 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: 09/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Female