MAUDE Adverse Event Report: WELCH ALLYN GREEN SERIES 777 INTEGRATED WALL SYSTEM; WALL TRANSFORMER

Model Number 77710

Device Problems Component Falling (1105); Device Slipped (1584); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

Welch allyn is reporting this event in an abundance of caution.A follow up report will be submitted when the evaluation is complete.

Event Description

Welch allyn received a report from a hospital with the allegation that a surgeon was in the process of raising the bed in a patient room that was not in clinical use when the bed came in contact with the integrated wall panel.The integrated wall panel lifted off of the wall mounted rail bracket, allowing the panel to drop onto the bed.There was no patient involved in the event.This occurred in a patient room that was new and not yet in clinical use.No one was hurt or injured in the event.The panel contained an aneroid blood pressure gauge and cuff, wall transformer, specula dispenser and thermometer, each mounted to the panel.The fallen panel sustained physical damage to the corner of the panel and the wall transformer.

Manufacturer Narrative

The actual device was not returned to welch allyn for evaluation.Photos of the device and the mounting were provided by the customer.Engineering concluded that an upward force placed on the wall panel is the most likely cause for the wall transformer board falling off the wall.The investigation has determined there is no evidence of a manufacturing defect.(b)(4).

• Brand Name: GREEN SERIES 777 INTEGRATED WALL SYSTEM
• Type of Device: WALL TRANSFORMER
• Manufacturer (Section D): WELCH ALLYN; 4341 state street road; skaneateles falls NY 13153
• Manufacturer (Section G): WELCH ALLYN; 4341 state street road; skaneateles falls NY 13153
• Manufacturer Contact: lauren neubauer ; 4341 state street road; p.o. box 220; skaneateles falls, NY 13153-0220 ; 3156853674
• MDR Report Key: 5130045
• MDR Text Key: 28055111
• Report Number: 1316463-2015-00043
• Device Sequence Number: 1
• Product Code: HMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 77710
• Device Catalogue Number: 77710-XXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1