MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY,M AIH, 1.6 DIA, W/SWITCH, 100-120V ONLY, PACK; INTERNAL HANDLE

Model Number 1011-0139-02

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

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 while attempting to defibrillate a patient (age & gender unknown), the internal handles defib output was out of specification.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The customer was contacted for return of the device.The customer has responded and indicated that the product will not be returned for evaluation.Therefore, this claim is closed as no sample returned.

• Brand Name: ASSY,M AIH, 1.6 DIA, W/SWITCH, 100-120V ONLY, PACK
• Type of Device: INTERNAL HANDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 15200303
• MDR Text Key: 297734964
• Report Number: 1220908-2022-02899
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 00847946022334
• UDI-Public: 00847946022334
• 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: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1011-0139-02
• Device Catalogue Number: 1011-0139-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2020
• 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