MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number UNK_MED

Device Problem Collapse (1099)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2017

Event Type  Injury  

Event Description

It was reported that a bed collapsed while occupied by a patient and that the patient sustained unknown injuries.No details were given regarding the cause of the bed's collapse or any possible medical intervention provided to the patient for the alleged injuries.

Manufacturer Narrative

The device involved in the alleged event was not identified for evaluation, and no further information was given at this time.Device involved in the alleged event could not be identified.

Event Description

It was reported that a bed collapsed while occupied by a patient and that the patient sustained unknown injuries.No details were given regarding the cause of the bed's collapse or any possible medical intervention provided to the patient for the alleged injuries.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7203676
• MDR Text Key: 97676846
• Report Number: 0001831750-2018-00052
• 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: 03/14/2018

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 Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 01/18/2018
• Supplement Dates Manufacturer Received: 12/22/2017
• Supplement Dates FDA Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: No
• 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