INFINITY DOCKING STATION IDS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-05-04 for INFINITY DOCKING STATION IDS manufactured by Draeger Medical Systems, Inc.

Event Text Entries

[107569521] A follow up report will be submitted upon completion of this investigation.
Patient Sequence No: 1, Text Type: N, H10

[107569522] The customer reported that the top of the infinity docking station (ids) came apart while in use and the delta monitor fell on a patient. No adverse patient impact was reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1220063-2018-00016
• MDR Report Key: 7486517
• Report Source: CONSUMER
• Date Received: 2018-05-04
• Date of Report: 2018-08-24
• Date of Event: 2018-04-20
• Date Mfgr Received: 2018-04-23
• Date Added to Maude: 2018-05-04
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. DHAVAL TRIVEDI
• Manufacturer Street: 6 TECH DRIVE
• Manufacturer City: ANDOVER MA 018102434
• Manufacturer Country: US
• Manufacturer Postal: 018102434
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: INFINITY DOCKING STATION IDS
• Generic Name: PATIENT MONITOR DOCKING STATION
• Product Code: DRQ
• Date Received: 2018-05-04
• Device Expiration Date: 2000-01-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DRAEGER MEDICAL SYSTEMS, INC
• Manufacturer Address: 6 TECH DRIVE ANDOVER MA 018102434 US 018102434

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-05-04