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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR
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BRAEMAR MANUFACTURING, LLC LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR Back to Search Results
Model Number MCT 3L
Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Patient Problems Burn(s) (1757); Caustic/Chemical Burns (2549)
Event Date 08/19/2019
Event Type  Injury  
Manufacturer Narrative
Description of alleged event: on (b)(6) 2019, the patient contacted lifewatch customer service to report the alleged incident dated (b)(6) 2019.Refer to synopsis for description of event as communicated by the patient.The patient call recordings for this event were reviewed on (b)(6) 2019, substantiating the written case description.Additional detail obtained from the call recording review was: the patient indicated that she was not warned by the doctor's office that batteries are not rechargeable.The patient repeatedly indicated that the batteries look like ordinary batteries and she did not realize that they could not be recharged.She indicated that she did not have her glasses to see the non-rechargeable warning imprinted on the battery.The patient indicated that the battery "exploded like a bomb"; flew out of the charger and burned her couch and blanket.The battery "pinged" around her mother's neck, travelled all the way down her mother's dress, wrapped around her underwear.This left a grapefruit size burned hole on her mother's buttock, causing first and second degree burn.The patient stated that her mother got first, second, and third degree burns and she had to call an ambulance.Her mother was provided wound care for acid burn and was admitted in the hospital for five (5) days.The patient said that she wants us to add a "big huge" warning so that the same incident can be avoided.The patient reported this event to her doctor's office and was reassured that the manufacturer would be notified.To date, lifewatch services, inc.Has not received any communication from the doctor's office regarding this event.After further follow up attempts, lifewatch quality analyst lead was able to speak with the patient on (b)(6) 2019 for clarification of events and receipt of pictures of physical injury and property damage.During this conversation, the patient provided the following clarification: ·the patient indicated that the doctor's office staff (undisclosed identity) had advised the patient that the batteries were rechargeable.The patient had previously indicated, per call recording review, that the doctor's office had not warned that the batteries are not rechargeable.The patient's mother has pre-existing medical conditions (congestive heart failure - already diagnosed previous to this event) that contributed to the duration of the hospital stay.The patient indicated that her mother was taken to the hospital the day of the event and upon observation/counseling, was advised to use barrier bandages and silvadene cream for the battery acid burn and was subsequently discharged.The patient indicated no other medical intervention was required and no prescription or otc medication was prescribed or recommended.The patient's mother returned to the hospital at a later date (undisclosed) for unrelated reasons due to pre-existing medical conditions.Device history record was reviewed, with no contributing factors identified.Refer to file for root cause investigation performed.The root cause of the event is user error.The patient attempted to recharge the provided saft lithium thionyl batteries.These batteries are not intended to be recharged.The effects of the battery recharge were battery explosion, resulting in physical injury and property damage from acid burn and flames.No additional information is known to braemar manufacturing, llc at this time.
 
Event Description
On (b)(6) 2019, patient reported that she placed the mct-3l sensor battery provided in the kit in a battery recharging system (not provided by the company) and the battery exploded causing fire and harm to her mother.The patient reported it burned her blanket and couch.She also reported the battery flew and hit her mother in the chest who has a pacemaker.It also caused her mother's dress to get on fire and caused burns.The patient reported that her mother was hospitalized and stayed for 5 days.Note: become aware date is (b)(6) 2019, which is the date that the patient contacted lifewatch services, inc.To report the event (b)(4).
 
Event Description
On (b)(6) 2019, patient reported that she placed the mct-3l sensor battery provided in the kit in a battery recharging system (not provided by the company) and the battery exploded causing fire and harm to her mother.The patient reported it burned her blanket and couch.She also reported the battery flew and hit her mother in the chest who has a pacemaker.It also caused her mother's dress to get on fire and caused burns.The patient reported that her mother was hospitalized and stayed for 5 days.Note: become aware date is (b)(6) 2019, which is the date that the patient contacted lifewatch services, inc.To report the event ((b)(4)).
 
Manufacturer Narrative
Description of alleged event: on (b)(6) 2019, the patient contacted (b)(4) customer service to report the alleged incident dated (b)(6) 2019.Refer to synopsis for description of event as communicated by the patient.The patient call recordings for this event were reviewed on 09/12/2019, substantiating the written case description.Additional detail obtained from the call recording review was: the patient indicated that she was not warned by the doctor's office that batteries are not rechargeable.The patient repeatedly indicated that the batteries look like ordinary batteries and she did not realize that they could not be recharged.She indicated that she did not have her glasses to see the non-rechargeable warning imprinted on the battery.The patient indicated that the battery "exploded like a bomb"; flew out of the charger and burned her couch and blanket.The battery "pinged" around her mother's neck, travelled all the way down her mother's dress, wrapped around her underwear.This left a grapefruit size burned hole on her mother's buttock, causing first and second degree burn.The patient stated that her mother got first, second, and third degree burns and she had to call an ambulance.Her mother was provided wound care for acid burn and was admitted in the hospital for five (5) days.The patient said that she wants us to add a "big huge" warning so that the same incident can be avoided.The patient reported this event to her doctor's office and was reassured that the manufacturer would be notified.To date, (b)(4), inc.Has not received any communication from the doctor's office regarding this event.After further follow up attempts, (b)(4) quality analyst lead was able to speak with the patient on 09/18/2019 for clarification of events and receipt of pictures of physical injury and property damage.During this conversation, the patient provided the following clarification: the patient indicated that the doctor's office staff (undisclosed identity) had advised the patient that the batteries were rechargeable.The patient had previously indicated, per call recording review, that the doctor's office had not warned that the batteries are not rechargeable.The patient's mother has pre-existing medical conditions (congestive heart failure - already diagnosed previous to this event) that contributed to the duration of the hospital stay.The patient indicated that her mother was taken to the hospital the day of the event and upon observation/counseling, was advised to use barrier bandages and silvadene cream for the battery acid burn and was subsequently discharged.The patient indicated no other medical intervention was required and no prescription or otc medication was prescribed or recommended.The patient's mother returned to the hospital at a later date (undisclosed) for unrelated reasons due to pre-existing medical conditions.Device history record was reviewed, with no contributing factors identified.Refer to attached file for root cause investigation performed.The root cause of the event is user error.The patient attempted to recharge the provided saft lithium thionyl batteries.These batteries are not intended to be recharged.The effects of the battery recharge were battery explosion, resulting in physical injury and property damage from acid burn and flames.No additional information is known to braemar manufacturing, llc at this time.Additional information: the affected ifu and qsg were updated to add additional battery life warning indications.No additional events of patients recharging non-rechargeable batteries have been received by (b)(4), inc.No additional information is known to (b)(4), inc.
 
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Brand Name
LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR
Type of Device
LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR
Manufacturer (Section D)
BRAEMAR MANUFACTURING, LLC
1285 corporate center drive
suite 150
eagan, mn MN 55121
MDR Report Key9151144
MDR Text Key167984510
Report Number2133409-2019-00013
Device Sequence Number1
Product Code DSI
UDI-Device Identifier00850725007033
UDI-Public00850725007033
Combination Product (y/n)N
PMA/PMN Number
K110499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 05/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2019
Is this an Adverse Event Report? Yes
Device Operator Lay User/Patient
Device Model NumberMCT 3L
Device Catalogue NumberACT3 UNIVERSAL GATEWAY
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2019
Event Location Home
Date Manufacturer Received09/09/2019
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age41 YR
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