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

Model Number AF19G100669

Device Problems Erratic or Intermittent Display (1182); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/11/2021

Event Type  malfunction  

Event Description

During stemi procedures the defibrillator screens went blank.Screen went blank towards the end of the stemi cath lab procedure.Screen went black while hooked up to a patient /plugged in during stemi cath lab procedure.Screen went black towards end of case cv (l) heart cath/acute mi.Screen went dark at the end of stemi procedure.Defibrillator attached to patient and monitoring from 1159 to 1540 continuously.Battery still showed the battery charge was full.Placed different battery in defibrillator with no change in screen.Left the defibrillator off for about one hour and checked the screen again.Battery still showed a full charge, but the screen remained dark (at 1530) no other patient information available on this case.Manufacturer response for zoll r-series als, zoll r-series als (per site reporter) our clinical engineering team has submitted 3 units to the r&d team at zoll and we await their findings.Manufacturer response for zoll r-series als, zoll r-series als (per site reporter).Our clinical engineering team has submitted 3 units to the r&d team at zoll and we await their findings.Manufacturer response for zoll r-series als, zoll r-series als (per site reporter).Our clinical engineering team has submitted 3 units to the r&d team at zoll and we await their findings.Manufacturer response for zoll r-series als, zoll r-series als (per site reporter) our clinical engineering team has submitted 3 units to the r&d team at zoll and we await their findings.

• Brand Name: R-SERIES
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 12860222
• MDR Text Key: 281143460
• Report Number: 12860222
• 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: 10/01/2021,09/29/2021

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 Operator: Other
• Device Model Number: AF19G100669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: White