MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; STRETCHER, WHEELED

Catalog Number UNK_MED

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Injury (2348)

Event Date 11/14/2015

Event Type  malfunction  

Event Description

It was reported that the patient was being loaded into the ambulance when the patient slid off the cot and was injured.It was alleged that the patient was not properly secured to the cot specifically in the shoulder area.It was not reported what type of injuries the patient received or the treatment needed.

Manufacturer Narrative

It was reported by the customer that as the patient was being loaded into the ambulance, the cot allegedly did not reach load height and as the patient leaned to one side, the cot tipped over and fell to the ground.The customer reported that the patient remained on the cot during the alleged tip and the patient was not injured.A visual and functional inspection was performed by the stryker field service representative who reported that there were no defects that would have caused or contributed to the alleged cot tip.

Event Description

It was reported that the patient was being loaded into the ambulance when the cot tipped over.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• Type of Device: STRETCHER, WHEELED
• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5270696
• MDR Text Key: 33007324
• Report Number: 0001831750-2015-00614
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

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: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2016
• 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