RAPID RESPONSE HUT RRHUT1017

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-24 for RAPID RESPONSE HUT RRHUT1017 manufactured by Medical Positioning, Inc..

Event Text Entries

[26650962]
Patient Sequence No: 1, Text Type: N, H10

[26650963] Performing a tilt table test. Patient passed out and the tilt table would not go down to supine position. Red emergency button did not work nor did the down button of the table control panel. Patient was beginning to seize when manually pulling the table to supine position. Manufacturer response for table examination - tilt, (brand not provided) (per site reporter): we will notify the manufacturer today or tomorrow. This unit had already been upgraded based on a previous recall.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5100210
• MDR Report Key: 5100210
• Date Received: 2015-09-24
• Date of Report: 2015-09-08
• Date of Event: 2015-07-23
• Report Date: 2015-07-01
• Date Reported to FDA: 2015-07-01
• Date Reported to Mfgr: 2015-07-01
• Date Added to Maude: 2015-09-24
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: BIOMEDICAL ENGINEER
• 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: 3

Device Details

• Brand Name: RAPID RESPONSE HUT
• Generic Name: TABLE, EXAMINATION, MEDICAL, POWERED
• Product Code: LGX
• Date Received: 2015-09-24
• Model Number: RRHUT1017
• Device Availability: Y
• Device Age: 2 YR
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDICAL POSITIONING, INC.
• Manufacturer Address: 1717 WASHINGTON ST KANSAS CITY, MO 64108 US 64108

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-09-24