MAUDE Adverse Event Report: LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY-REVERSE

Model Number 404007

Device Problem Positioning Failure (1158)

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

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary: fse investigated customer report that the table would not move up with either the foot control or hand control, but since that occurrence, they have not had any more issue with table movement.Fse could not duplicate the issue.Fse checked hand/foot switch cables, reconnected, verified lift transducer connections, could not find any issue with table movement.Verified operation according to service checklist (b)(4) and returned the unit to full service.A review of cts shows no similar issues reported on this unit.Impact assessment summary: na.Root / probable cause code.Unknown.Root / probable cause summary.Refer to investigation summary.No further investigation needed at this time.Qa will continue to monitor and trend for similar issues.No capa at this time, these trends and issues are reported on during quality metrics review and during the management review meetings to consider input for corrective action.Complaint confirmed.No.Disposition summary.Unit remained in service.

Event Description

Incident reported by facility on (b)(6) 2020 for an event that occurred on (b)(6) 2020.Facility stated the table intermittently locking up with no movement.During the incident, patient was on the bed under anesthesia.Also, it did happen after the bed was moved horizontally.

• Brand Name: HUT EXT DR FINAL ASSY-REVERSE
• Type of Device: HUT EXT DR FINAL ASSY-REVERSE
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e. galbraith rd; cincinnati OH 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e. galbraith rd
• MDR Report Key: 10516266
• MDR Text Key: 224847426
• Report Number: 1518293-2020-00024
• Device Sequence Number: 1
• Product Code: IXR
• 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,health profession
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/14/2020

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: Health Professional
• Device Model Number: 404007
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1