MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY,MAIH, 2.7 DIA, W/SWITCH, 100-120V ONLY, PACKA; INTERNAL PADDLE

Model Number 1011-0139-03

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown), the associated device's defib output was out of specification using these internal paddles.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

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

Manufacturer Narrative

The complainant was contacted for return of the device.The device has not been returned to zoll for evaluation.

• Brand Name: ASSY,MAIH, 2.7 DIA, W/SWITCH, 100-120V ONLY, PACKA
• 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: 15462945
• MDR Text Key: 300420941
• Report Number: 1220908-2022-03511
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 00847946022341
• UDI-Public: 00847946022341
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

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?: No
• Device Operator: Other
• Device Model Number: 1011-0139-03
• Device Catalogue Number: 8011-0139-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 08/31/2022
• Supplement Dates FDA Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1