MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AUTOCLAVABLE INTERNAL HANDLES

Model Number 1003-0143-04

Device Problem Output below Specifications (3004)

Patient Problem No Information (3190)

Event Date 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

Please refer to the attached user medwatch report that zoll medical has received.Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.[(b)(4) medwatchreport__.Pdf].

Event Description

Complainant alleged that while attempting to defibrillate a one year old female patient at five joules, the device only discharged one joule.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 suspect product.The customer has responded and indicated the product will not be returning to zoll.

• Brand Name: AUTOCLAVABLE INTERNAL HANDLES
• 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: 8258522
• MDR Text Key: 133459391
• Report Number: 1220908-2019-00056
• 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: 12/28/2018

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: 1003-0143-04
• Device Catalogue Number: 1003-0143-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/28/2018
• Initial Date FDA Received: 01/17/2019
• Supplement Dates Manufacturer Received: 12/28/2018
• Supplement Dates FDA Received: 01/25/2019
• 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
• Patient Age: 1 YR