MAUDE Adverse Event Report: ZOLL MEDICAL; SYSTEM, PACING, TEMPORARY, ACUTE, INTERNAL ATRIAL DEFIBRILLATION

Model Number 8011-1050-01

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Insufficient Information (4580)

Event Date 04/22/2021

Event Type  malfunction  

Event Description

Coming off bypass, patient with v-fib , surgeon wanted to shock with internal defib paddles, defib paddles charged , surgeon unable to deliver shock with paddles.Defibrillator machine tested in the morning (am), internal defibrillator paddles not tested during case.Shocked patient with external paddles, converted to normal sinus rhythm, no further intervention for defibrillator needed.Internal defibrillator paddles sequestered.Internal paddles sent to biomedical engineering for testing and evaluation.

• Type of Device: SYSTEM, PACING, TEMPORARY, ACUTE, INTERNAL ATRIAL DEFIBRILLATION
• Manufacturer (Section D): ZOLL MEDICAL; 269 mills road; chelmsford MA 01824
• MDR Report Key: 11752122
• MDR Text Key: 248165412
• Report Number: 11752122
• Device Sequence Number: 1
• Product Code: MTE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8011-1050-01
• 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: 04/23/2021
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28835 DA