• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SCOTTCARE CORPORATION TELESENTRY (BATTERY) MOBILE CARDIAC TELEMETRY MONITOR (BATTERY) Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTELESENTRY (BATTERY)
Type of DeviceMOBILE 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 Key5644645
MDR Text Key44886134
Report Number1527715-2016-00001
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 02/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTS01
Device Catalogue Number101109B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/18/2016
Device Age4 YR
Event Location Home
Date Manufacturer Received01/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-