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

Catalog Number UNK_MED

Device Problem Device Alarm System (1012)

Patient Problems Fall (1848); Injury (2348)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

Serial number not yet provided.

Event Description

It was reported there was a patient fall, and the staff believed the bed alarm was on, but it did not ring upon the patient's exit.The patient sustained an unspecified injury.

Manufacturer Narrative

After investigation, the cause for the bed exit allegedly not alerting the clinician was found to not be related to a defect with the product.The patient was allegedly injured as a result of the event.Based on information provided regarding the event and a labeling review, this issue was likely attributed to the user not successfully setting the bed exit alarm.

Event Description

It was reported there was a patient fall, and the staff believed the bed alarm was on, but it did not ring upon the patient's exit.The patient sustained an unspecified injury.

• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8809829
• MDR Text Key: 151698623
• Report Number: 0001831750-2019-00608
• 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: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2019
• 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