MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS REUSABLE ESOPHAGEAL/RECTAL TEMPERATURE PROBE, INFANT

Model Number	21076A
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unable to confirm serial number.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that the plastic piece is broken of the temperature probe.The device was in use on a patient.There was no report of patient or user harm.

• Brand Name: REUSABLE ESOPHAGEAL/RECTAL TEMPERATURE PROBE, INFANT
• Common Device Name: NA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10143506
• Report Number: 1218950-2020-03390
• Device Sequence Number: 3184267
• Product Code: FLL
• UDI-Device Identifier: 00884838001008
• UDI-Public: (01)00884838001008
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K962070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2020

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: Health Professional
• Device Model Number: 21076A
• Device Catalogue Number: 989803100891
• Device Lot Number: 19-95728
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1