MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; BED,BASIC, SEMI ELECTRIC

Model Number MDR107002E

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Smoking (1585)

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

Event Date 05/05/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported, "remote burnt up while in patient home.Began smoking.Smells like an electrical fire inside remote.No one injured." email received from (b)(6) facility representative, (b)(6) solutions.Reporter states, bed was purchased in our system (b)(6) 2020, and the bed has been in service in this patients home since (b)(6) 2021.The incident occurred (b)(6) 2021 while the patient was in the bed.Reporter states, "remote burnt up while in patient home.Began smoking.Smells like an electrical fire inside remote.No one injured." reporter states, there was no fluid egress noted in or around any of the electrical components of the bed or remote.The sample is available for return and evaluation.Due to the nature of the reported incident and in an abundance of caution, this med watch is being filed.If any further relevant information is identified or obtained, a supplemental med watch will be submitted.

Event Description

It was reported, "remote burnt up while in patient home.Began smoking.Smells like an electrical fire inside remote.No one injured.".

Event Description

It was reported, "remote burnt up while in patient home.Began smoking.Smells like an electrical fire inside remote.No one injured.".

Manufacturer Narrative

Supplemental documentation changed/additional information added.D9 device available for evaluation -yes, sample received 6/09/2021.G6 type of report - follow-up.H2 if follow-up what type? additional information, device evaluation.H3 device evaluated by manufacturer - yes.H6 type of investigation- 10.H5 investigation conclusion - (b)(4)/defect confirmed: unknown responsible party h10 investigation report reads as follows: (b)(6) 2021 10:05:58 cst (brallo) "material number: mdr107002e.Sample and/or photo provided? sample & photo (quantity provided:1).Lot number? no.Defect(s) from complaint: (b)(4).Investigation results: confirmed.Investigation conclusion / root cause: "the customer is stating that the remote began to smoke.Inspected the power cord and noticed that some of the internal wires are exposed near the base of the pendant.The plug has all five pins still intact.Tested the pendant and all of the buttons worked except for two.The head section up and down button did not function when tested.At this time it is undermine if the sample came in contact with any liquid substance.However, the up button for the head section seems to be stuck.The sample that was received has been sent to the manufacture for further testing.Sample was sent to the manufacture on 6/18/202.".

• Brand Name: MEDLINE
• Type of Device: BED,BASIC, SEMI ELECTRIC
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11913542
• MDR Text Key: 256569128
• Report Number: 1417592-2021-00098
• Device Sequence Number: 1
• Product Code: LLI
• UDI-Device Identifier: 40080196320999
• UDI-Public: 40080196320999
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDR107002E
• Device Catalogue Number: MDR107002E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention