MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AUTOCLAVABLE INTERNAL HANDLES (MSERIES); DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Model Number 8011-0501-01

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 09/18/2017

Event Type  malfunction  

Event Description

After removing the defibrillator internal paddle handles, the technician noted cracking of the handle running axially down the handles and near the energy discharge button.The user found three handle assemblies with these cracks.Two of the handle assemblies were less than 1 year old while the third handle assembly was approx.Two years old.Sterilization frequencies were evaluated at less than 150 cycles.This cracking issue has been previously reported to medwatch and manufacturer.Handles were removed from service and sent to biomedical engineering (bme) for reporting.Bme to contact manufacturer for reporting and analysis.Bme reviewed sterilization requirements @ 134dec for 4-5 minutes with drying time @10-14 minutes in pre-vacuum steam sterilizer.The sterile processing department (spd) confirmed this protocol with their logs and information from our processing standardization vendor.Spd also informed biomedical that rotational force was needed many times to removed threaded paddle/spoon from handle.They were concerned that this may be contributing to the failure of these handles.Biomedical sequestered a paddle to send with the handles for evaluation.

• Brand Name: AUTOCLAVABLE INTERNAL HANDLES (MSERIES)
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 6906665
• MDR Text Key: 87874361
• Report Number: 6906665
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/21/2017,09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8011-0501-01
• Device Catalogue Number: 8011-0501-01
• Other Device ID Number: M SERIES STYLE A
• 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: 09/21/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: STEAM STERILIZER