MAUDE Adverse Event Report: BEDS BY GEORGE, INC. BEDS BY GEORGE; HAVEN 3000

Model Number 3000

Device Problems Material Separation (1562); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

Problem typically seen when patient overloads the seem and exhibits aggressive behaviors (e.G., kicking) not intended by the design parameters of the standard mesh canopy (heavy duty mesh is recommended).However, dealer insists this patient does not exhibit these behaviors and is not aggressive.

Event Description

(b)(6) was contacted by dealer about a tear in the fabric of a canopy on a haven bed.In specific, the mesh (standard strength) pulled away from the fabric in the door panel.Through an investigation between the dealer and the family, it was determined that the patient using the bed did not exhibit any aggressive behaviors and was using the bed within the acceptable use and design parameters of the standard mesh canopy.At the conclusion of the investigation, there was no definitive reason found as to the tear in the mesh and it was determined to be a manufacturing anomaly and a new canopy was provided under warranty provision.

• Brand Name: BEDS BY GEORGE
• Type of Device: HAVEN 3000
• Manufacturer (Section D): BEDS BY GEORGE, INC.; 219 caravan drive; elkhart IN 46514
• Manufacturer (Section G): BEDS BY GEORGE, INC.; 109 14th ave.; s building 2; middlebury IN 46540
• Manufacturer Contact: mark salaiz ; 219 caravan drive; elkhart, IN 46514 ; 5743332310
• MDR Report Key: 10577375
• MDR Text Key: 208387782
• Report Number: 3008830652-2020-00002
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3000
• Device Catalogue Number: 3000
• Device Lot Number: BRIDENBACKER 070219
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 09/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 27