MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO SPR PLUS II BED CUSHION; BED, FLOTATION THERAPY, POWERED

Catalog Number CL212

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Injury (2348)

Event Date 02/07/2017

Event Type  Injury  

Manufacturer Narrative

Investigation results showed that the patient had fractured her wrist during a previous fall, and the customer was unable to confirm if the fracture mentioned in this report was due to the recent fall, or if it was caused by the previous fall.Also, upon evaluation of the unit, it was found that the user was over-inflating the overlay, which can reduce siderail coverage.The issue was resolved for the customer by the stryker sales representative performing an in-service to train the customer on proper use of the overlay.

Event Description

It was alleged that an elderly dementia patient fell and broke her wrist.The patient received an x-ray, but no further details regarding medical intervention was reported.The customer reported that, although they do not know if the patient fell out of the bed, or if she exited the bed and then fell, they were concerned that there is inadequate siderail coverage due to the height of the mattress in relation to the height of the siderail.The customer was not able to identify the particular bed or surface related to this incident.

Manufacturer Narrative

Investigation results showed that the patient had fractured her wrist during a previous fall, and the customer was unable to confirm if the fracture mentioned in this report was due to the recent fall, or if it was caused by the previous fall.Also, upon evaluation of the unit, it was found that the user was over-inflating the overlay, which can reduce siderail coverage.The issue was resolved for the customer by the stryker sales representative performing an in-service to train the customer on proper use of the overlay.

Event Description

It was alleged that an elderly dementia patient fell and broke her wrist.The patient received an x-ray, but no further details regarding medical intervention was reported.The customer reported that, although they do not know if the patient fell out of the bed, or if she exited the bed and then fell, they were concerned that there is inadequate siderail coverage due to the height of the mattress in relation to the height of the siderail.The customer was not able to identify the particular bed or surface related to this incident.

• Brand Name: SPR PLUS II BED CUSHION
• Type of Device: BED, FLOTATION THERAPY, POWERED
• 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: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6389556
• MDR Text Key: 69446655
• Report Number: 0001831750-2017-00061
• Device Sequence Number: 1
• Product Code: IOQ
• 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: 09/12/2017

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?: No
• Device Operator: No Information
• Device Catalogue Number: CL212
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2017
• Initial Date FDA Received: 03/08/2017
• Supplement Dates Manufacturer Received: 02/07/2017
• Supplement Dates FDA Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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