MAUDE Adverse Event Report: CARDIO MEDICAL PRODUCTS, INC. CMP DEFIBRILLATION ECG ELECTRODE; EXTERNAL DEFIB PADS

Model Number LOH401-S

Device Problem Arcing (2583)

Patient Problems Death (1802); Erythema (1840); Burn, Thermal (2530)

Event Date 02/11/2014

Event Type  Death  

Event Description

(b)(6) old, female in persistent vfib and vtach.Received 3 discharges from a lifepak20 through the cmp defib pad and with the 4th discharge an arc was observed in a location where the disposable defibrillator pad was positioned, which caused a red mark, burn to the pt and the staff removed the defibrillator pads and replaced with pads from the same lot number.The second set of pads performed as advertised.(unfortunately, we do not know where the health care provider positioned the d-fib pads).We also do not have any physical evidence that the pads malfunctioned, since the staff did not retain the product and discarded any evidence.The staff indicated that the electrical connection on the external defib pads had been compromised.However, we have no evidence or product to inspect.The following discharge escalation was used on the first pair of disposable pads: 200j, 300j, 360j.Unfortunately, the initial pads were not retained, for inspection or to send to manufacturer.The staff indicated that the foam backing on the pad was intact on visual inspection.Lot #: y032212-02.This same department alerted us to a similar event several months prior to this one.It appears that the problem was only present in the emergency department.The main campuses and other locations have been using the same product for over two (2) years without any incident or events.In fact, over 10,000 external defibrillator pads have been used without any incident by the william beaumont system.We conducted a thorough inspection and testing for product, conductivity and continuity of pads.The pads continue to perform at peak performance without any issue.We have not been able to replicate the complaint and can only determine that the staff did not follow the ifu's and/or did not prep the patients skin properly prior to placement.(b)(4).

Manufacturer Narrative

The hospital did not retain/save the product in question, so we could not evaluate efficacy of the product.However, sample products from the same lot number were returned and evaluated by our testing lab.All sample products performed to prescribed standards.The product was returned to our manufacturing facility for evaluation and it was determined that the product was working within the designed parameters.This event is the second event reported by the same facility, which we believe may not be following the ifu's correctly, especially during a stressful, code situation and may inadvertently compromise the product or not properly position the product on the pt.Since the staff did not save the product, but somehow indicated that the connection where the electricity passes into the pad had broken down.We have no physical evidence that this occurred.If the staff had determined a product failure, we are perplexed that their standard protocol would be to discard the product.This same department removed the backing from a defibrillator pad incorrectly exposing wires and metal rivets that caused arcing during a similar type event last november.The product from that event was saved and returned to our lab for testing.The results were that the pads continued to deliver multiple charges in spite the health care provider opening the package incorrectly and removing protective covering, while exposing bare wires before placing defib pads on pt.The product that was directly related to the event was not returned to us.Only the product that was left of the shelf was returned.We requested that all product with the same lot number be returned to us after the first event, even though the test results indicated that there was no product failure.Ref event #2246340-2013-00001.During that investigation, it was determined that the user did not follow proper application procedures when removing the backing from the pad.

• Brand Name: CMP DEFIBRILLATION ECG ELECTRODE
• Type of Device: EXTERNAL DEFIB PADS
• Manufacturer (Section D): CARDIO MEDICAL PRODUCTS, INC.; 385 franklin ave; suite l; rockaway NJ 07866
• Manufacturer Contact: 385 franklin ave; suite l; rockaway, NJ 07866 ; 8002273633
• MDR Report Key: 3708638
• MDR Text Key: 4263080
• Report Number: 2246340-2014-00001
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2016
• Device Model Number: LOH401-S
• Device Catalogue Number: LOH401-S
• Device Lot Number: Y032213-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR