MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEART START XL; DEFIBRILLATOR

Model Number M4735A

Device Problem Fire (1245)

Patient Problems Lead(s), Burn(s) From (3161); Shock from Patient Lead(s) (3162)

Event Date 06/05/2019

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation.

Event Description

It was reported to philips that a (b)(6) years old female patient in a hospital¿s intensive care unit, experienced an event of pulseless ventricular tachycardia, received cardiopulmonary resuscitation (cpr) rescue efforts via the heartstart xl, experienced a defibrillator pads burn, and another defibrillator was required in order to resuscitation the patient.During shock five, a fire suddenly appeared from the pad lead wire on the patient¿s left side of her body.The fire traveled from the left pad lead wire to the patient¿s left eyelash, left forehead, and the hair on her head adjacent to the left forehead.Post shock five fire, resuscitation efforts continued, which included a sternotomy, cannulation placement (vessels not reported) for and initiation of extracorporeal membrane oxygenation (ecmo) therapy, and defibrillation of the heart via another manufacturer¿s defibrillator and internal paddles; brand and model not reported.Philips is considering this event to be a serious injury based on the report that the treatment was interrupted requiring the use of another defibrillator.

Event Description

It was reported to philips that a four-year-old female patient, in the hospital¿s intensive care unit, experienced an event of pulseless ventricular tachycardia.Cardiopulmonary resuscitation (cpr) was started and the patient was defibrillated using the heartstart xl defibrillator.During the resuscitation a flame was observed, and the patient was noted to have burns on the chest, abdomen, and face.Another defibrillator was used to continue treatment to the patient.On (b)(6) 2019, the patient went into pulseless ventricular tachycardia (vt).Cpr was initiated, and philips m3716a defibrillator pads were placed and connected to the heartstart xl defibrillator.During the resuscitation effort, five shocks were delivered (30, 30, 50, 50 and 100j respectively).Philips m3716a adult/child radiolucent multifunction electrode pads were used during this event.Photographs were provided of the involved pads and the patient¿s burns.The photographs showed the wire to the involved defib pad had a blackened section and the side borders of the pads appear melted and curled back with some areas of blackening.The left lateral chest/abdomen had areas of redness and blistering that correspond with the melted, irregular borders of the pictured defibrillator pad.No necrotic areas were noted.In addition, there was a discrete, curved marking on the skin that was dark red, without blistering, in an area that would have been underneath the defibrillator pad.Additional pictures of the child show singed eyelashes and eyebrow (above the left eye) and singed hair along the left temple and forehead.The left temple and pre-auricular areas are reddened with some areas of blistering.It was reported that these areas were treated with topical agents.The information provided is consistent with the defib pad wire being underneath the defib pad.The wire under the pad, paired with an accumulation of either oxygen or flammable anesthetic gas under the surgical drape, likely resulted in the flame, which spread to the left side of the patient¿s body when the 5th shock was delivered.The heartstart xl instructions for use (ifu) provides the following warnings: ¿during defibrillation, air pockets between the skin and the multifunction defib electrode pads may cause patient skin burns.To help prevent air pockets, make sure the pads completely adhere to the skin.¿ and ¿do not use the heartstart xl in a flammable or oxygen-rich atmosphere.This can cause an explosion hazard.¿ (heartstart xl ifu, 13-29).The burns experienced by the patient are a known risk if the pads are used in an oxygen-rich environment or the user is not careful about air pockets.The customer did not provide the defibrillator or pads for evaluation by philips.The defibrillator remains with the customer.

Manufacturer Narrative

Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.H3 other text : pictures were provided by the customer.

• Brand Name: HEART START XL
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 8746001
• MDR Text Key: 149566571
• Report Number: 1218950-2019-04691
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K001725
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M4735A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 06/07/2019
• Supplement Dates FDA Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 23