MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION R SERIES:ALS, AND E SERIES; MONITOR, DEFIBRILLATOR

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

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Bone Fracture(s) (1870); Pneumonia (2011); Septic Shock (2068)

Event Date 07/18/2019

Event Type  malfunction  

Event Description

The report has been submitted after an intensivist at our hospital expressed concern regarding the zoll monitor that gives feedback during cpr.The intensivist was running a code in which the code team followed the prompts from the monitor, and later it was found that the patient had two acute thoracic compression-type fractures.Patient coded.Zoll monitor and pads used to run code.Per rn, the zoll monitor kept telling the team "deeper, deeper" in regards to their chest compressions; so they attempted to compress deeper.Pt returned to sinus rhythm at seven minutes later.The required two doses of epinephrine (1 mg).At 0859, patient had an abdominal ct which showed: interval development of inferior endplate fracture at t11 with widening of the intervertebral disc space at t11-t12, as well as nondisplaced posterior spinous process fracture at t12.Recommendations for further evaluation with mri to assess for ligamentous injury.Radiologist spoke with the intensivist and told him that this is a compression-type fracture, and could be from the cpr.This patient was subsequently made a dnr, and passed away that afternoon from septic shock and pneumonia.

• Brand Name: R SERIES:ALS, AND E SERIES
• Type of Device: MONITOR, DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 8909848
• MDR Text Key: 154861593
• Report Number: 8909848
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2019
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31390 DA
• Patient Weight: 58