MAUDE Adverse Event Report: CARDIO MEDICAL PRODUCTS DEFIBRILLATION/CARDIOVERSION/MONO OR BIPHASIC PACING/ECG ELECTRODE; DEFIBRILLATION PAD

Model Number LOH401-S

Device Problems Degraded (1153); Arcing (2583)

Patient Problem Burn, Thermal (2530)

Event Date 12/10/2014

Event Type  No Answer Provided  

Event Description

A pt was brought in as a cpr and was found to be in persistent vfib and vtach while pulse-less and unresponsive.The defibrillation pads in the resuscitation room were used and after 3 defibrillations, the fourth defibrillation arced visible and burned the pt.The pads had to be changed out.After the code ended, it was found that the portion of the pad where electricity goes into the pad had broken down from defibrillation.No parts were missing.This is the third time this had happened during a cpr in er in the resus room with the cmp defib pads.The pt's skin was intact, there was no hair on their skin, the pads made direct contact and intact prior to each defibrillation.The incident is a safety concern to pts and staff, as well as a delay in critical care when the pads have to be switched out during a code.The specific pad from this event and packaging were not kept, so no specific analysis can be done.This pad is from the same lot number y032213-02 seen previously and the outcome is similar to our previous report.It has been reported to the mfr and all pads from that lot number have been returned for assessment.As part of the investigation, the defibrillation device, a lifepak 20, was sequestered with biomedical engineering for investigation.All tests have passed.There are no errors in the error log, and there is nothing in the lp20 pt archive from the date of the event; the archive from the date of this event is longer there.Uf/report number - (b)(4).

• Brand Name: DEFIBRILLATION/CARDIOVERSION/MONO OR BIPHASIC PACING/ECG ELECTRODE
• Type of Device: DEFIBRILLATION PAD
• Manufacturer (Section D): CARDIO MEDICAL PRODUCTS; 385 franklin ave, ste l; rockaway NJ 07866
• MDR Report Key: 3647146
• MDR Text Key: 4183037
• Report Number: MW5034693
• Device Sequence Number: 1
• Product Code: LDD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/01/2016
• Device Model Number: LOH401-S
• Device Lot Number: Y032213-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2014
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIFEPAK20
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR