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

Model Number 3500

Device Problems Material Puncture/Hole (1504); Material Perforation (2205); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2020

Event Type  malfunction  

Manufacturer Narrative

Event Description

Beds by george (bbg) was contacted by a remote technician for numotion in (b)(6).The technician was in ct but the family and the bed are in (b)(6).The family has a bbg haven canopy bed and on monday evening, the father (b)(6) noticed a tear in the foot section/panel of his daughter's bed.The tear was roughly 18" long.At this time, the family made the decision to cease using the bed until the canopy could be fixed.The next day they contacted their dealer and got in touch with remote tech in ct who they were able to discuss the issue with.This was not a live tech but a tech simply by phone.They explained the issue to him (b)(6) and sent him pictures of the tear in the fabric/mesh.He then contacted bbg and relayed this informaton at which time bbg initiated its own investigation of the issue.(b)(6) call (b)(6) back and asked him several follow up questions as to how the tear happened and how long it had been like this.Unfortunately, brad did not have answers to these questions because he had not acutally seen the bed and only spoken with the family on the phone.At this time, it was decided to have an additional 3-way call with the father to do an analysis of how the tear occured and if the patient using the bed was within the design parameters and how to provide a solution.During the 3-way call, the father was able to provide an answer that he only noticed the tear the night before and that his daughter was not aggressive, did not display aggressive behaviors like kicking or thrashing and he felt that the standard mesh should be sufficient rather than upgrade to a 'heavy duty' mesh (which would not be covered under warranty).He did say that the possible cause of the issue was his daughter rocks her bottom against the foot panel every night, but not aggressively.Bbg concluded that the standard mesh should have held up, but that the family likely needed to make sure there was not added constant pressure against the sides such as blankets or stuffed animals as there appeared to be in the picture.They also explained the importance to keep the fabric rolled and taute so this could be avoided.Lastly, it was discussed again if the family felt this would happen again and the reason for hd mesh was for situations where they feel the child exhibits behaviors that require a stonger environment.The dad did not feel this was necessary and understood that should this happen again, they would need to go to an hd mesh and it would not be covered under warranty.

• Brand Name: BEDS BY GEORGE
• Type of Device: HAVEN
• Manufacturer (Section D): BEDS BY GEORGE, INC.; 219 caravan drive; elkhart, in
• Manufacturer (Section G): BEDS BY GEORGE, INC.; 109 14th ave.; s building 2; middlebury, in
• Manufacturer Contact: adam davis ; 219 caravan drive; elkhart, in ; 3332310403
• MDR Report Key: 9964613
• MDR Text Key: 198518049
• Report Number: 3008830652-2020-00001
• 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: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/15/2020

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: 3500
• Device Catalogue Number: 3500
• Device Lot Number: Z. COLIAS 092019
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/14/2020
• Initial Date FDA Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 4 YR
• Patient Weight: 15