MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AUTOCLAVABLE INTERNAL HANDLES (MSERIES); INTERNAL PADDLE

Model Number 8011-0501-01

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that during functional testing, the internal paddles failed the test.This was all the information provided.Complainant did not indicate that there was any patient involvement in the reported malfunction.

Manufacturer Narrative

The customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.

Manufacturer Narrative

Zoll medical corporation evaluated the internal handles with removable spoons and the customer's report was not replicated or confirmed.The device was put through extensive testing which included multiple 10j and 30j testing using a test device and simulator, continuity testing, and visual inspection without duplicating the report.The internal handles and removable spoons were scrapped.No trend is associated with reports of this type.

• Brand Name: AUTOCLAVABLE INTERNAL HANDLES (MSERIES)
• 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: 8789377
• MDR Text Key: 150991382
• Report Number: 1220908-2019-01994
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K963781
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2019

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: 8011-0501-01
• Device Catalogue Number: 8011050101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 06/24/2019; 06/24/2019
• Supplement Dates FDA Received: 08/19/2019; 02/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2018
• 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