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Model Number 2700-D
Device Problem Defective Component (2292)
Patient Problem Physical Entrapment (2327)
Event Date 04/12/2019
Event Type  malfunction  
Manufacturer Narrative
Consumer requested beds by george employee to come to family's home and evaluate the bed, take the requested measurements, and make necessary fixes. I (b)(6) informed her that this would be the responsibility/role of her dme dealer (authorized bbg dealer) ans she would need to contact them to arrange this or we could do this on her behalf. However, in the meantime, we would be able to help her with any pictures and data she was able to provide. Upon providing pictures and measurements we requested, we were able to determine the issue was an improperly made and undersized mattress without need for someone to physically inspect the bed and involve the dealer, which the mother did not want to do.
Event Description
(beds by george originally reported this event on may 13, 2019 via hard copy submission. It was returned stating we needed to submit electronically). Mattress provided with bed was undersized (from manufacturer vendor). This created an unwanted and inappropriate gap between the mattress and sides. A new mattress was immediately ordered a provided to consumer with the correct dimensions. Consumer was instructed to cease using until new mattress arrived. In specific, (b)(6) (mom) called into beds by george (bbg) offices friday morning ((b)(6) 2019). She found her daughter burrowed under the mattress the night before. She said her daughter was completely fine and calm and that there were no injuries, but that her daughter had managed to wedge herself between the mattress and the side and then burrow up under the mattress. In her words, she said her daughter likes to burrow and it is comforting for her, but of course for safety reasons, she doesn't want this to continue. I (b)(6) told her we agreed and informed her she should not use the bed during this time until the issue can be resolved. I asked many follow up questions. I asked her if this had ever happened before in the previous 4 months they had the bed and she said it had not. This was the first time with regard to this bed. I also asked how the use of the bed has been since acquiring it and if there have been any other issues. (b)(6) said the bed has worked great and they love it. This is the first time they have had any issues. I specifically asked about the use of the dual adjust deck and she said it has worked great and they've had no problems. I once again asked if she is certain there were no injuries to her daughter during the incident, and she reiterated that she was fine and there were no physical issues. She went on to mention that after she removed her daughter from the bed, she put her back in to see if she'd try to do this behavior again (burrow), and within minutes she had begun to wedge herself between the door and the mattress again. I asked if the sides fo the bed were tight against the mattress and she said no. There said there was about 1" to 1. 5" gap that they can easily put their hand down. I told her this is not normal or acceptable and that i thought this might mean the mattress is undersized and we needed to get some dimensions to verify. I specifically asked for the width and length of the mattress out of the bed frame. I also asked for the dimensions of the frame itself, both from interior pad to interior pad (inside of bed frame and with door closed) and wood to wood. I next spoke with (b)(6) (husband & stepdad) several times on friday both on the phone and via text. He sent multiple e-mails with links to pics of the bed as requested. He also sent pics via text that showed the dimensions of the mattress out of the bed. Based on the pics, the mattress does look narrower than the 54" it is supposed to be but i told him i would speak with (b)(6) on monday to see what the best solution was. In the meantime, i informed (b)(6) that it was our official recommendation to cease using the bed immediately. I explained this was extremely important to adhere to, especially if they felt there was a safety risk/concern and until we could verify if the mattress was the issue and get them a new mattress that would solve the issue. However, they informed me that the family was going to purchase a standard full-size mattress from a standard retail location that would be more rigid and tighter against the sides and not allow the child to burrow. On the following monday ((b)(6) 2019), i (b)(6) discussed this with (b)(6) and looked over the pictures provided by the family. He verified with the mattress manufacturer/vendor what the dimensions should be for the mattress provided. The vendor confirmed it is a little undersized based on the pictures. In this instance, (b)(6) said the best solution is a new all foam full size mattress that was slightly over-sized. This would be more rigid and not be able to collapse as much at the side nor be pulled back. On (b)(6) 2019 an order for a new full size mattress (54x74) was placed with beds by george's mattress vendor. This was communicated to the family via text message (to (b)(6)) and told there would be no additional cost and was being shipped to them directly when the mattress was ready. I (b)(6) was contacted by (b)(6) on (b)(6) 2019 via text message about the mattress, in specific how it had not yet been received. I informed her that we were actually notified on (b)(6) 2019 that the mattress was ready from the vendor and i would be picking it up the morning of (b)(6) 2019 and it would likely ship out on the following monday, (b)(6) 2019. I explained that i was traveling until late on the (b)(6) and was not able to pick it up until the morning of the 27th (which was a saturday). (b)(6) acknowledged this in her response and simply asked for tracking information once the mattress was shipped. However, upon arriving to the vendor, the mattress could not be located by the staff on site and they asked for us to return on monday or tuesday of the coming week to pick it up. Accordingly, beds by george picked up and shipped the mattress directly to the address provided by the (b)(6) on (b)(6) 2019. I (b)(6) notified (b)(6) via e-mail the following morning of (b)(6) 2019 and provided a copy of the shipping label. The mattress arrived and was received at the family's home on (b)(6) 2019 at 5:11 that evening. There has been no additional communication with the (b)(6) at any time since the last communication on the (b)(6) 2019, and they have not proactively contact beds by george since (b)(6) text on (b)(6) 2019. However, beds by george did attempt to contact them on (b)(6) 2019 and again on (b)(6) 2019 but with no response. No response was provided after beds by george's communication to them on (b)(6) 2019.
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Manufacturer (Section D)
1045 n. nappanee st.
elkhart IN 46514
Manufacturer (Section G)
109 14th ave.
s building 2
middlebury IN 46540
Manufacturer Contact
adam davis
1045 n. nappanee st.
elkhart, IN 46514
MDR Report Key8869216
MDR Text Key218537499
Report Number3008830652-2019-00001
Device Sequence Number1
Product Code FNJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Administrator/Supervisor
Remedial Action Replace
Type of Report Initial
Report Date 05/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2700-D
Device Catalogue Number2700-D
Device Lot NumberSEWELL 060518-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/07/2019 Patient Sequence Number: 1