MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION INTERNAL PADDLE, ASSY, MAIH,2.0 DIA, W/SWITCH

Model Number 1011-0139-05

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Complainant alleged that these internal handles are not functioning.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 customer has responded and indicated the product will not be returning to zoll.

• Brand Name: INTERNAL PADDLE, ASSY, MAIH,2.0 DIA, W/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: 5156327
• MDR Text Key: 28703841
• Report Number: 1220908-2015-02733
• 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: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1011-0139-05
• Device Catalogue Number: 8011-0139-05
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/30/2015
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2012
• 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