MAUDE Adverse Event Report: WELCH ALLYN INC CUFF, WA, REUSABLE, THIGH; CUFF, BLOOD PRESSURE, REUSABLE

Model Number REUSE-13

Device Problem Insufficient Information (3190)

Patient Problem Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

The hillrom /welch allyn blood pressure cuffs are noninvasive blood pressure cuffs intended for use in conjunction with non-automated and automated sphygmomanometers to determine blood pressure in pediatric through adult patients.The ifu warns "do not apply cuff to areas on patient where skin is delicate or damaged.Check cuff site frequently for irritation.The vsm 6000 monitoring device is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for noninvasive blood pressure (nibp), pulse rate (pr), noninvasive functional oxygen saturation of arteriolar hemoglobin (spo2), an body temperature in normal and axillary modes.The vsm 6000 can be programmed to continuous blood pressure monitoring.In the event continuous monitoring is used the ifu instructs "warning patient injury risk.Do not use the nibp for continuous monitoring without frequently checking the patient's limb.When a patient is being monitored frequently or for a prolonged period, regularly remove the cuff to inspect it and to check the cuff site for ischemia, purpura, or neuropathy.Multiple attempts to obtain additional details regarding the event, including confirmation of the use of a hillrom device as well as specific injury details (preexisting wound at site, patient's medical history, the determined need for debridement (poor wound healing, date of wound, date of debridement, means of bp measurement (single measurement or continuous, etc) were unsuccessful.It is noted that the customer is declining to provide any additional information.Although the customer did not provide the necessary details to conclude that a hillrom device was utilized in this event, if it were determined that a hillrom device was involved, based on the report that the hematoma spanned from the patient's "thigh to calf " and required "extensive treatment and surgical debridement" indicates that the injury sustained meets the definition of serious injury requiring medical intervention to prevent permanent impairment of a body function or body structure and therefore would be considered reportable.

Event Description

The customer reported the facility " had an incident where a patient developed an extensive hematoma from thigh to calf which needed extensive treatment and debridement." it is noted that the customer utilizes multiple blood pressure measurement devices (hillrom/welch allyn, as well as 3rd party vendor devices and could not confirm that a hillrom device (bp cuff with vsm 6000 monitoring device) was used during this event.The customer reported they had 10 hillrom devices and 1 3rd party; however, they could not state which device was being used and did not note any issues or concerns with the functionality of the device this complaint has been captured under hillrom ref # (b)(4).

• Brand Name: CUFF, WA, REUSABLE, THIGH
• Type of Device: CUFF, BLOOD PRESSURE, REUSABLE
• Manufacturer (Section D): WELCH ALLYN INC; 4341 state street road; skaneateles falls NY 13153
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 14945422
• MDR Text Key: 295419243
• Report Number: 1316463-2022-00101
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00732094065749
• UDI-Public: 732094065749
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: REUSE-13
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other