MAUDE Adverse Event Report: STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS SPIRIT SELECT; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 5700

Device Problem Device Fell (4014)

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

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 1 malfunction event, where it was reported the device experienced a litter/lift unexpected collapse/drop.There was no patient involvement.

Manufacturer Narrative

The final device was evaluated in the field but the issue was not confirmed; no malfunction or defect was found.

Event Description

This report summarizes 1 malfunction event, where it was reported the device experienced a litter/lift unexpected collapse/drop.There was 1 event with patient involvement, but no reports of adverse consequences.

• Brand Name: SPIRIT SELECT
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS; 1020 adelaide st. s.; N6E 1 R6; CA N6E 1R6
• MDR Report Key: 12696765
• MDR Text Key: 278385022
• Report Number: 3006433555-2021-00039
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327284546
• UDI-Public: 07613327284546
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5700
• Device Catalogue Number: 5700000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1