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

Model Number R SERIES PLUS

Device Problems Unable to Obtain Readings (1516); Appropriate Term/Code Not Available (3191)

Patient Problem Extubate (2402)

Event Date 01/25/2020

Event Type  Injury  

Event Description

Pt needed to be extubated due to malfunction of capnometry.Reintubated, capnometer briefly worked, then no reading.Fda safety report id# (b)(4).

• Brand Name: ZOLL R SERIES PLUS
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 9706395
• MDR Text Key: 179432371
• Report Number: MW5092971
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: R SERIES PLUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR