MAUDE Adverse Event Report: SCOTTCARE CORPORATION TELESENTRY (BATTERY); MOBILE CARDIAC TELEMETRY MONITOR (BATTERY)

Model Number TS01

Device Problems Fire (1245); Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 01/18/2016

Event Type  malfunction  

Manufacturer Narrative

Scottcare has received a single reported incident of this nature for this specific model battery since the battery was commercially released in 4/28/2010.Approximately, (b)(4)batteries have been produced and shipped to customers, to date, which provides an approximate (b)(4) failure rate.The failure occurred during the charging of the battery, which can only be charged while detached from the telesentry cardiac monitor.Furthermore, the telesentry mct monitor is shipped with two batteries, each charged and used on alternate days when provided to the patient.As such, we do not foresee an immediate threat of injury or death for this battery.Thus, this will likely be a class ii recall, requiring relabeling with "date of manufacture" and "use by date." we will also subsequently evaluate sourcing a new battery cell and redesigning the plastic compartment that houses the battery cell.Scottcare plans to take the following actions by march 15, 2016: include "date of manufacture" and "use by date" (set at two years from the date of manufacture) on all new batteries for future sales.Send a letter to all customers who have received these batteries in the past with the following corrective actions: batteries older than two years: inform the customer of the potential battery issue and ensure they are aware of our 2 year use guidline in our manual.If the customer is no longer using the battery, advise the customer to properly dispose the battery per scottcare's telesentry ts01 operator manual (pd-100975).Batteries less than two years: inform the customer of the potential battery issue and ask them to return the battery for relabeling with proper "date of manufacture"" and "use by date.".If the customer is no longer using the battery, advise the customer to properly dispose the battery per scottcare's telesentry ts01 operator manual (pd-100975).Concurrently, scottcare will evaluate and test an alternative cell which complies with the iec62133 standard and assess a redesign of the cell compartment as recommended by the battery manufacturer.Scottcare plans to complete these actions by april 30, 2016.

Event Description

A scottcare customer, calling on the behalf of their client, contacted scottcare on (b)(6) 2016 stating that a li-ion battery for the telesentry mobile cardiac telemetry monitor had "exploded" while charging at a patient's home.The customer clearly stated that no one was injured by the battery's event.The battery was returned by the patient to our customer on (b)(6) 2016 and ultimately returned to scottcare on (b)(6) 2016.Scottcare was able to see the battery had a catastrophic event with evidence of charring on the battery materials and some residue on the plastic battery shell.Scottcare's investigation of the shell did not uncover any evidence of explosion, melting of the plastic, or disfigurement one would expect with an "explosion" but rather something akin to smoldering as evidenced by the residue on the battery shell.Scottcare was not able to determine if the battery had been stored properly by the customer and the patient or had been exposed to any adverse environmental conditions such as excessive moisture or heat.The device was sent to the battery manufacturer (batteryspace.Com/aa portable power) for further investigation.

• Brand Name: TELESENTRY (BATTERY)
• Type of Device: MOBILE CARDIAC TELEMETRY MONITOR (BATTERY)
• Manufacturer (Section D): SCOTTCARE CORPORATION; 4791 w. 150th street; cleveland OH 44135
• Manufacturer (Section G): SCOTTCARE CORPORATION; 4791 w. 150th street; cleveland OH 44135
• Manufacturer Contact: michael ensor ; 4791 w. 150th street; cleveland, OH 44135 ; 2163620550
• MDR Report Key: 5644645
• MDR Text Key: 44886134
• Report Number: 1527715-2016-00001
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TS01
• Device Catalogue Number: 101109B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/18/2016
• Device Age: 4 YR
• Event Location: Home
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 74 YR