MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AUTOCLAVABLE HANDLE ASSEMBLY WITHOUT SWITCH; INTERNAL PADDLE

Model Number 8011-0500

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

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 during biomed testing, the internal handles failed to discharge.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

The customer's report was observed during initial testing; however after disassembling the internal handles to determine root cause, the report was no longer seen.The internal handles were put through extensive testing without duplicating the report.The handles were scrapped and a replacement set of handles were sent to the customer.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: AUTOCLAVABLE HANDLE ASSEMBLY WITHOUT SWITCH
• Type of Device: INTERNAL PADDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 9911772
• MDR Text Key: 186008616
• Report Number: 1220908-2020-00829
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963781
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

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: 8011-0500
• Device Catalogue Number: 8011-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 04/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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