MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY, MAIH, 1.0 DIA,W/SWITCH, 100-120V ONLY, PACKA; INTERNAL HANDLE

Model Number 1011-0139-01

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Information (3190)

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 associated device was unable to obtain an ecg signal via (b)(6).Complainant indicated that the clinician obtained another set of paddles to continue treating the patient.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 the return of the suspect product.The customer has responded and indicated that the product has been removed from clinical use and will not be returning to zoll at this time.

• Brand Name: ASSY, MAIH, 1.0 DIA,W/SWITCH, 100-120V ONLY, PACKA
• Type of Device: INTERNAL HANDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 11048043
• MDR Text Key: 222795028
• Report Number: 1220908-2020-04128
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 00847946022327
• UDI-Public: 00847946022327
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

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: 1011-0139-01
• Device Catalogue Number: 1011-0139-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1