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

Model Number 9538

Device Problems Moisture Damage (1405); Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2009

Event Type  malfunction  

Event Description

It was reported that one of the two n-sized batteries included with the patient activator (pa) packaging was leaking.The packaging contents were discussed and the caller was informed that a new battery should be able to be found at a hardware store.The pa was not returned at the time of the call.No patient complications have been reported as a result of this event.

Manufacturer Narrative

This event was assessed and is being reported as a part of a retrospective review of events, which was in response to mdr criteria revisions and on-going process improvements.(b)(4).

• Brand Name: REVEAL DX
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 1190 0; MY 11900
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4609794
• MDR Text Key: 5695457
• Report Number: 3004593495-2015-00033
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2009

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9538
• Device Catalogue Number: 9538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1