MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION INTERNAL HANDLE; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Model Number 1003-0143-04

Device Problem Sticking (1597)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 02/02/2017

Event Type  malfunction  

Event Description

Patient was coding due to a mammary arterial laceration.Chest was opened in the operating room (or) and the patient had pretty much bled out.Massive transfusion protocol initiated, code continued to run, the interior defibrillator (defib) spoon paddles were attempted to be used but the button that is used to discharge the shock was stuck.Second pair of paddles was opened and used.This patient's prognosis was very grim and according to the ct surgeon this failure was not a contributing issue to the patient's death.The arterial bleed was significant at one point there was no blood in the heart at all.Manufacturer response for zoll internal defibrillator paddles, (brand not provided) (per site reporter): i have not heard any follow up from the manufacturer at this time.

Manufacturer Narrative

The following elements have blank data.

Event Description

Patient was coding due to a mammary arterial laceration.Chest was opened in the operating room and the patient had pretty much bled out.Massive transfusion protocol initiated, code continued to run, the interior defibrillator (defib) spoon paddles were attempted to be used but the button that is used to discharge the shock was stuck.Second pair of paddles was opened and used.This patient's prognosis was very grim and according to the ct surgeon this failure was not a contributing issue to the patient's death.The arterial bleed was significant at one point there was no blood in the heart at all.Manufacturer response for zoll internal defibrillator paddles, (brand not provided) (per site reporter).I have not heard any follow up from the manufacturer at this time.

• Brand Name: INTERNAL HANDLE
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269-271 mill road; chelmsford MA 01824
• MDR Report Key: 6335143
• MDR Text Key: 67609105
• Report Number: 6335143
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 1003-0143-04
• Device Catalogue Number: 8011050101
• Other Device ID Number: 8011-0501-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR