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

Catalog Number 5700000000

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.The 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(s), where it was reported.There was patient involvement; the patient sustained a laceration.

Event Description

This report summarizes 1 malfunction event(s), where it was reported.There was patient involvement; the patient sustained a laceration.

Manufacturer Narrative

This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.The device was not evaluated, however the issue was discussed with the customer.It was determined the customer attempted to remove a shipping pin without using a tool, resulting in a laceration.There was no defect with the device.There was no remedial action taken.This device is not labeled for single use.

• 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: 9240734
• MDR Text Key: 165483536
• Report Number: 3006433555-2019-00046
• 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: 12/19/2019

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: No Information
• Device Catalogue Number: 5700000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 10/01/2019
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1