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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2021

Event Type  malfunction  

Event Description

It was reported that the joint that attaches to the base frame of the bed came loose, causing the lift to partially collapse and the litter to tilt on an angle.The bed was in use by a patient at the time of the event and they did not suffer any adverse consequences as a result.The user facility is currently being contacted to gather more details and potentially schedule an inspection.

Manufacturer Narrative

Upon further investigation, this product is handled by the stryker endoscopy division.A supplemental record will be filed with the correct manufacturer information and details upon completing of investigation.

Event Description

It was reported that the joint that attaches to the base frame of the bed came loose, causing the lift to partially collapse and the litter to tilt on an angle.The bed was in use by a patient at the time of the event and they did not suffer any adverse consequences as a result.Upon further investigation, this product is handled by the stryker endoscopy division.A supplemental record will be filed with the correct manufacturer information and details upon completing of investigation.

• 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: kelsey barla ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 13010722
• MDR Text Key: 282277292
• Report Number: 0001831750-2021-01649
• 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: 02/22/2022

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 Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 11/24/2021
• Supplement Dates FDA Received: 02/22/2022
• 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