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

Model Number 1003-0143-04

Device Problem Failure to Discharge (1169)

Patient Problem Death (1802)

Event Date 02/02/2017

Event Type  Death  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.Please refer to the attached user medwatch report that zoll medical has received.B)(4).

Event Description

Complainant alleged that while attempting to treat a b)(6) year old male patient, the associated device 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 it was not a result of the reported malfunction.

Manufacturer Narrative

The internal handles were returned to zoll medical corporation for evaluation.Testing of the internal handles did not duplicate the customer's report.The internal handles were capable of discharging up to 50 joules and passed multiple self tests.There was no physical evidence that the internal handles were damaged or that the shock button could become stuck.The internal handles pass continuity testing and full functional testing.The clinical data was not available as part of this investigation.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ASSY,AUTOCLVBL,INTERNAL HANDLES
• Type of Device: 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: 6416017
• MDR Text Key: 70296602
• Report Number: 1220908-2017-00537
• 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: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2017
• 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: 03/20/2017
• Is the Reporter a Health Professional?: No
• Event Location: Outpatient Diagnostic Facility
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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
• Patient Age: 62 YR