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

Catalog Number UNK_MED

Device Problem Device Fell (4014)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/28/2022

Event Type  Injury  

Event Description

It was reported by mdr report #: mw5111351, that the bed fell when the cna raised the bed with the patient on it.It was reported that the motor for the head end hi/lo support bracket failed causing the bed to fall.The patient complained of back pain and an x-ray was ordered which revealed a right scapular hairline fracture.

Manufacturer Narrative

The unit was inspected by a third party service and it was identified that the unexpected drop was due to a broken/damaged hi/lo motor.It was further identified the bed was unable to be repaired.Multiple attempts were made to gather additional information.However, no response was received.

Event Description

It was reported by mdr report #: mw5111351, that the bed fell when the cna raised the bed with the patient on it.It was reported that the motor for the head end hi/lo support bracket failed causing the bed to fall.The patient complained of back pain and an x-ray was ordered which revealed a right scapular hairline fracture.

• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 15439805
• MDR Text Key: 300067485
• Report Number: 0001831750-2022-00919
• 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,Followup
• Report Date: 01/13/2023

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 Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 08/25/2022
• Supplement Dates FDA Received: 01/13/2023
• 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
• Patient Outcome(s): Other