MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AUTOCLAVABLE INTERNAL HANDLES, MOLDED

Model Number 1011-0140-01

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 during biomed testing, the associated device allowed too high joule output using these internal paddles.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

The complainant was contacted for return of the device.The customer has responded and indicated that the event internal handles were discarded and they are not available for evaluation.

• Brand Name: AUTOCLAVABLE INTERNAL HANDLES, MOLDED
• 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: 14428116
• MDR Text Key: 295350378
• Report Number: 1220908-2022-01747
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 00847946022372
• UDI-Public: 00847946022372
• 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: 04/25/2022

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: 1011-0140-01
• Device Catalogue Number: 8011-0140-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 04/25/2022
• Supplement Dates FDA Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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