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

Catalog Number UNK_MED

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bruise/Contusion (1754); Fall (1848); Swelling (2091); Dizziness (2194)

Event Date 02/03/2017

Event Type  malfunction  

Event Description

It was reported that a patient allegedly fell from a stryker bed.It was alleged that the hydraulic system failed to support the patient.It was reported that the patient experienced a bruised elbow, swollen ankle, and dizziness.The patient was reportedly released from the hospital following an evaluation by the hospital personnel.No additional details were given regarding the extent of the injuries or any possible additional medical intervention.

Manufacturer Narrative

The unit was not repaired as this is now being handled by stryker's legal department.

Event Description

It was reported that a patient allegedly fell from a stryker bed.It was alleged that the hydraulic system failed to support the patient.It was reported that the patient experienced a bruised elbow, swollen ankle, and dizziness.The patient was reportedly released from the hospital following an evaluation by the hospital personnel.No additional details were given regarding the extent of the injuries or any possible additional medical intervention.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• 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: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6472943
• MDR Text Key: 72392398
• Report Number: 3006433555-2017-00064
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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