MAUDE Adverse Event Report: TCM COMBIM MODULE

Model Number	903-111
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	07/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please note that the tcm combim monitoring system consist of a tcm base unit (item number: 391-880) and the combim module (903-111).The combim module is referenced as this is the affected model in this report, however please note that the serial number and udi number provided, is associated to the tcm base unit, as this is the only serial number currently known from the complaint.Further, please not that the manufacturing date in field is associated to the base unit (391-880).In the report the serial number and associated udi number has been stated for the base unit with serial number: 880r0467n005.As the customer is not sure whether the base unit involved in the incident was the one with serial number (b)(4), the udi for n006 is included here: (b)(4).
Event or Problem Description
A set of twins 32 weeks of age were monitored by two tcm combim monitors (serial numbers (b)(4)).Twin (a) appeared to have a bruise on her outer thigh.The customer also states that this patient has similar deep red marks bilaterally as well on her back; up by her shoulders.The other twin (b) had no concerns or issues at this time.The customer reached out for a wound consult who recommended to use radiogel sheets every 2 to 3 days and follow up.Both monitors were taken off the patients and no longer in service.The customer states she does not know which monitor was on each twin, but the monitor ending in n005 was set to 44 degrees c, site time set to 6 hours, and the co2 alarm is set to off.The monitor ending in n006 was set to 42 degrees.Have not confirmed if the co2 alarm was on or off or the length of time set on the site time.Both monitors time and date was incorrect.The sensor placement on twin a was alternating between outer legs beginning at 1030 am on 7/15 to 7/16.On 7/17 the sensor placement changed to the back for approx.For 6 hours until it was removed off of twin a on the morning of 7/17.At this time both monitors were taken off of both babies.
Event or Problem Description
A set of twins 32 weeks of age were monitored by two tcm combin monitors (serial numbers (b)(6) and (b)(6)).Twin (a) appeared to have a bruise on her outer thigh.The customer also states that this patient has similar deep red marks bilaterally as well on her back; up by her shoulders.The other twin (b) had no concerns or issues at this time.The customer reached out for a wound consult who recommended to use radiogel sheets every 2 to 3 days and follow up.Both monitors were taken off the patients and no longer in service.The customer states she does not know which monitor was on each twin, but the monitor ending in n005 was set to 44 degrees c, site time set to 6 hours, and the co2 alarm is set to off.The monitor ending in n006 was set to 42 degrees.Have not confirmed if the co2 alarm was on or off or the length of time set on the site time.Both monitors time and date was incorrect.The sensor placement on twin a was alternating between outer legs beginning at 1030 am on (b)(6) to (b)(6).On (b)(6) the sensor placement changed to the back for approx.For 6 hours until it was removed off of twin a on the morning of (b)(6).At this time both monitors were taken off of both babies.

• Brand Name: TCM COMBIM MODULE
• Common Device Name: TCM COMBIM MODULE
• MDR Report Key: 10407704
• Report Number: 1523456-2020-00002
• Device Sequence Number: 2476563
• Product Code: LKD
• UDI-Device Identifier: 05700699031112
• UDI-Public: (01)05700699031112
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2020
• Report Date (Section F): 09/07/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 903-111
• Device Catalogue Number: 903-111
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/15/2020
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 09/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 WK
• Date Report Sent to FDA: 09/07/2020