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

Catalog Number UNK_MED

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2023

Event Type  malfunction  

Event Description

It was reported that the device's scale is off by 300 lbs.And they can't get it to zero.No patient was affected, and no adverse consequence or clinically relevant delay in treatment was reported.Attempts are being made to gather additional details from the user facility.

Event Description

It was reported that the device's scale is off by 300 lbs.And they can't get it to zero.No patient was affected, and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

After investigation, the cause for the alleged issue could not be confirmed.A stryker field service technician opened a work order to record the customer's alleged issue.However, the device was not able to be identified and was not available at the time of the service visit.The issue was resolved by cancelling the work order.If the customer is able to identify the device and would like to have it evaluated in the future, a new work order can be opened, and stryker will be made readily available for the customer.H3 other text: unable to determine specific device, not available for evaluation.

• 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: alex wibert ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 18049060
• MDR Text Key: 327088601
• Report Number: 0001831750-2023-01328
• 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: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• 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
• Date Manufacturer Received: 10/02/2023
• 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