MAUDE Adverse Event Report: LINET SPOL. S R.O. MULTCARE; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 1MC17350-754

Device Problem Sparking (2595)

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

Event Date 04/20/2022

Event Type  malfunction  

Manufacturer Narrative

Linet received voluntary facility malfunction report, mw5110203 on june 23, 2022.Reporter stated, "cord was caught when bed in lowest position, spark and burned bed.No harm to pt, pt moved to another bed.Fda safety report id# (b)(4)." occuring on (b)(6) 2022.Bed was repaired by reporting facility on april 21, 2022, with following remarks, "troubleshooting, bed lowered onto power cord, cutting cord, replaced power cord and checked bed functions." facility provided this evidence to linet americas on 6/29/2022 as wo# (b)(4).The multicare bed requires an effective maintenance program.Preventative maintenance will minimize downtime due to excessive wear and tear.Examine the power cords for cuts, nicks, breaks, frays, and grounding.It is unknown if the facility performed any preventative maintenance on this bed.Facility technician replaced the damage power cord to resolve the issue.Based on this information, no further action is required.

Event Description

Fda notified manufacturer of report, (mw5110203) was received through fda's medwatch program on june 23, 2022.This report stated event as "cord was caught when bed in lowest position, spark and burned bed.No harm to pt, pt moved to another bed.Fda safety report id# (b)(4).".

• Brand Name: MULTCARE
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): LINET SPOL. S R.O.; zelevcice 5; slany, kladno 27401 ; EZ 27401
• Manufacturer (Section G): LINET SPOL. S R.O.; zelevcice 5; slany, kladno 27401 ; EZ 27401
• Manufacturer Contact: jakub polasek ; zelevice 5; slany, kladno 27401 ; EZ 27401
• MDR Report Key: 15083962
• MDR Text Key: 296399867
• Report Number: 3008058231-2022-00001
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1MC17350-754
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1