MAUDE Adverse Event Report: UMANO MEDICAL INC FL23P; MANUAL BED

Model Number FL23P

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 04/22/2019

Event Type  malfunction  

Event Description

It was reported that a manual hospital bed was found with 2 broken/damage braking casters resulting in brakes not holding.

• Brand Name: FL23P
• Type of Device: MANUAL BED
• Manufacturer (Section D): UMANO MEDICAL INC; 230 boulevard nilus-leclerc; l'islet, quebec G0R 2 C0; CA G0R 2C0
• Manufacturer (Section G): UMANO MEDICAL INC; 230 boulevard nilus-leclerc; l'islet, quebec G0R 2 C0; CA G0R 2C0
• Manufacturer Contact: maude thibault ; 230 boulevard nilus-leclerc; l'islet, quebec G0R 2-C0 ; CA G0R 2C0
• MDR Report Key: 8804669
• MDR Text Key: 200681774
• Report Number: 3009591865-2019-00014
• Device Sequence Number: 1
• Product Code: FNJ
• 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,foreign,user faci
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FL23P
• Device Catalogue Number: FL23P
• Date Manufacturer Received: 06/20/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1