MAUDE Adverse Event Report: SPAN MEDICAL PRODUCTS CANADA ULC SPAN; HOSPITAL BED

Model Number QD1000B

Device Problem Break (1069)

Patient Problems Fall (1848); Damage to Ligament(s) (1952)

Event Date 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

The entire rad939 assist bar was not returned but we did receive teh sa9013 subassembly (without the qp3435 snap button).Qs4072 bar mount separated into two pieces with the lower base tube broken off due to a weld failure.Poor plug weld penetration in between the qm3390 support tube and qp3332 inner tube caused the failure.The was manually welded in 2017, and is the only known failure of this nature since the product introduction in 2011.No further action is required.

Event Description

The patient was using the pivot assist bar to help him get out of bed, and the bar broke causing the patient to fall to the floor.The fall resulted in a sprained wrist.

• Brand Name: SPAN
• Type of Device: HOSPITAL BED
• Manufacturer (Section D): SPAN MEDICAL PRODUCTS CANADA ULC; 4658 ontario street; beamsville, on L0R 1 B4; CA L0R 1B4
• Manufacturer (Section G): SPAN MEDICAL PRODUCTS CANADA ULC; 4658 ontario street; beamsville, on L0R 1 B4; CA L0R 1B4
• Manufacturer Contact: william darby ; 4658 ontario street; beamsville, on L0R 1-B4 ; CA L0R 1B4
• MDR Report Key: 12100921
• MDR Text Key: 262038235
• Report Number: 8022290-2021-00001
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: QD1000B
• Device Catalogue Number: QD1000B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 163