MAUDE Adverse Event Report: REMOTE DIAGNOSTIC TECHNOLOGIES (RDT) TEMPUS IC PRO; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	00-1002
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer disposed the parts.
Event or Problem Description
As described by the customer "tempus ic li-ion battery exploded while being charged by tempus battery charger".Initial evaluation based on the customer communications reveal that tempus ic pro, the affected product built & shipped to our customer, us socom (us special forces), back in 2011.Adventure medics, who reported this complaint, purchased either from govt auction or from ebay.There is no further evaluation possible for this case since customer disposed the battery debris and the product is end of life.Cause could not be determined.Customer has been informed about product end of life and no support from philips for the parts.

• Brand Name: TEMPUS IC PRO
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): REMOTE DIAGNOSTIC TECHNOLOGIES (RDT); ascent 1, aerospace centre; aerospace boulevard; farnborough ; UK
• Manufacturer (Section G): REMOTE DIAGNOSTIC TECHNOLOGIES (RDT); ascent 1, aerospace centre; aerospace boulevard; farnborough ; UK
• Manufacturer Contact: selvaganesan balu ; ascent 1, aerospace centre; aerospace boulevard; farnborough ; UK
• MDR Report Key: 14716134
• Report Number: 3003832357-2022-00009
• Device Sequence Number: 16739159
• Product Code: MWI
• UDI-Device Identifier: 05060472440297
• UDI-Public: 05060472440297
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 00-1002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown