MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY,AUTOCLVBL,INTERNAL HANDLES; AUTOCLAVABLE INTERNAL HANDLES

Model Number 1003-0143-04

Device Problem Failure to Deliver Energy (1211)

Patient Problem Death (1802)

Event Date 12/23/2018

Event Type  Death  

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Event Description

Complainant alleged that while attempting to defibrillate a male patient (age unknown) with a gunshot wound, the associated defibrillator failed to discharge using these internal handles.Complainant indicated that the clinician obtained another set of internal handles to continue treating the patient.Complainant indicated that the patient subsequently expired; however they do not believe this was associated with the handles.

Manufacturer Narrative

The device was returned to zoll medical corporation.The internal handles were tested and the reported problem was confirmed.It was observed that the handles were in use for 56 months and have most likely met the life span of 100 autoclave cycles.Communication with the customer indicated that the internal handles were not tested prior to use, following sterization or tracked in terms of the number of cycles they have been exposed to.Information has been communicated to the customer.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ASSY,AUTOCLVBL,INTERNAL HANDLES
• Type of Device: AUTOCLAVABLE INTERNAL HANDLES
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 8283035
• MDR Text Key: 134269217
• Report Number: 1220908-2019-00173
• 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: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 1003-0143-04
• Device Catalogue Number: 1003-0143-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 01/28/2019
• Supplement Dates Manufacturer Received: 01/07/2019
• Supplement Dates FDA Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death