MED SYSTEMS ELECTRO FLO 5000 PERCUSSOR, 30 POWER/FREQUENCY SETTINGS AN NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-21 for MED SYSTEMS ELECTRO FLO 5000 PERCUSSOR, 30 POWER/FREQUENCY SETTINGS AN NA manufactured by Med System, Inc..

Event Text Entries

[121707750] Reason for report: initial hospitalization while enrolled in a clinical trial. Participant was in a phase 4 observational study ((b)(6)) for the efficacy, within fda indications, of med systems electro flo 5000 (k031876). Participant had been using the physician prescribed device in an indicated fashion for approx 2 weeks prior to hospitalization on a daily basis. At 22:02 est on (b)(6) 2018, participant self reported going to the hosp and sending a message to pi via secure email (hipaa secure 45 cfr part 164 and 21 cfr part 11 complaint) stating: "i got sick with a virus or something over the weekend, was admitted to (b)(6) hosp tonight. " participant was contacted at 12:48 pm est on (b)(6) 2018 about the event and asked to consult with prescribing physician on the continued use of the electro flo 5000 and was informed that all study data collection should be stopped until the prescribing physician and participant discussed the event and if he should continue at a later time. Participant is still in procession of the electro flo 5000 at the hosp, but informed clinical trial sponsor and pi about returning device at a later date after being cleared by this attending physician. Dose or amount: 1 an, frequency: daily, route: device makes contact with epidermis. Dates of use: (b)(6) 2018 - (b)(6) 2018. Diagnosis or reason for use: assist in airway clearance therapy/promote airway clearance.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5080064
• MDR Report Key: 7901907
• Date Received: 2018-09-21
• Date of Report: 2018-09-20
• Date of Event: 2018-09-17
• Date Added to Maude: 2018-09-24
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: MED SYSTEMS ELECTRO FLO 5000 PERCUSSOR, 30 POWER/FREQUENCY SETTINGS AN
• Generic Name: ELECTRO FLO PERCUSSOR 5000
• Product Code: BYI
• Date Received: 2018-09-21
• Model Number: ELECTRO FLO 5000
• Catalog Number: NA
• Lot Number: NA
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MED SYSTEM, INC.
• Manufacturer Address: SAN DIEGO CA 92117 US 92117

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2018-09-21