MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO S3 EX - 3005; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number 3005S3EX

Device Problems Application Program Problem: Dose Calculation Error (1189); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 05/10/2019

Event Type  malfunction  

Event Description

It was reported that a patient was given an incorrect dosage of medicine due to the scale on the bed being inaccurate, which resulted in a deterioration of the patient's health.No further details of the patient's health are available at this time.Upon inspection of the bed it was found that it had been zeroed incorrectly.

Manufacturer Narrative

The user facility clarified that the patient was not injured as a result of the incorrect dosage of medicine.

Event Description

It was reported that a patient was given an incorrect dosage of medicine due to the scale on the bed being inaccurate, which did not result in a deterioration of the patient's health.Upon inspection of the bed it was found that it had been zeroed incorrectly.

• Brand Name: S3 EX - 3005
• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8679750
• MDR Text Key: 147374408
• Report Number: 0001831750-2019-00584
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327278309
• UDI-Public: 07613327278309
• 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: 06/25/2019

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: 3005S3EX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 05/10/2019
• Supplement Dates FDA Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2018
• 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