MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD REVEAL; DETECTOR AND ALARM, ARRHYTHMIA

Model Number	PA96000
Medical Device Problem Codes	Device Emits Odor (1425); Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient activator battery was melting the plastic and was developing a hole around the battery area also had a smell of burnt plastic.The patient was advised to dispose the patient activator correctly.The patient activator is expected to be replaced.No patient complications have been reported as a result of this event.

• Brand Name: REVEAL
• Common Device Name: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• MDR Report Key: 7460043
• Report Number: 3004593495-2018-00359
• Device Sequence Number: 1007432
• Product Code: DSI
• UDI-Device Identifier: 00643169571129
• UDI-Public: 00643169571129
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K150117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2018

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: Lay User/Patient
• Device Model Number: PA96000
• Device Catalogue Number: PA96000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR