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

Catalog Number 0000000001

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2015

Event Type  malfunction  

Event Description

It was reported via repair work order that the power cord was damaged with exposed bare wiring.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: MDET TAXABLE
• 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
• Manufacturer (Section G): STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS; 1020 adelaide st. s.; N6E 1 R6; CA N6E 1R6
• Manufacturer Contact: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5330986
• MDR Text Key: 35032331
• Report Number: 3006433555-2015-00435
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2015

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: 0000000001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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