FDA Adverse Event Injury Summary report: N

OHIO MEDICAL PRODUCTS

MDR report key: 2993951 · Received February 28, 2013

Report

Report Number
MW5029218
Event Type
Injury
Date Received
February 28, 2013
Date of Event
February 4, 2013
Report Date
February 18, 2013
Manufacturer
OHIO MEDICAL PRODUCTS
Product Code
BTI
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
WI, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

ON (B)(6) 2013, PT WAS SET UP WITH AIR COMPRESSOR WITH HUMIDITY FOR TRACH. EQUIPMENT WAS WORKING, APPROPRIATELY, AT TIME OF SET UP. AT, APPROXIMATELY, 10:40PM, THE ON-CALL RT WAS PAGED AND THE PT'S WIFE STATED THAT THE AIR COMPRESSOR WAS OVER HEATING AND SHUTTING OFF. EQUIPMENT WAS A (B)(6) RENTAL AND RT WAS AWARE THAT THERE WAS NO BACK UP EQUIPMENT AVAILABLE AT (B)(6) TO EXCHANGE UNIT. SO PROCEEDED TO CALL (B)(6) TO ATTEMPT TO GET A REPLACEMENT AIR COMPRESSOR. RT STATED THE IMPORTANCE OF THE ISSUE TO THE (B)(6) STAFF MEMBER, SINCE IT WAS (B)(6) RENTAL EQUIPMENT THAT WAS MALFUNCTIONING. (B)(6) STAFF STATED THERE WAS NO MORE AIR COMPRESSORS IN THEIR WAREHOUSE AT THE PRESENT TIME AND HOPED IT WOULD CONTINUE TO WORK THROUGH THE NIGHT. UPON F/U WITH THE PT'S WIFE IN THE AM, SHE STATED THE AIR COMPRESSOR DID NOT WORK CONSISTENTLY THROUGH THE NIGHT. THE UNIT WOULD HEAT UP AND SHUT OFF AND ONCE IT COOLED OFF IT WOULD TURN BACK ON FOR A SHORT AMOUNT OF TIME, THEN SHUT DOWN AGAIN. RT DEPARTMENT WAS ABLE TO GET A REPLACEMENT AIR COMPRESSOR THE NEXT MORNING AND EXCHANGE THE EQUIPMENT. DOSE OR AMOUNT: AIR COMPRESSOR VIA TRACH, FREQUENCY: AS NEEDED FOR 6-9 MONTHS. DIAGNOSIS OR REASON FOR USE: V55.0 TRACHEOSTOMY, 161.9 MALIGNANT LARYNX, 141.0 MALIGNANT TONGUE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
87209 OHIO MEDICAL PRODUCTS HIGH VOLUME AIR COMPRESSOR BTI OHIO MEDICAL PRODUCTS CAA0111

Patients

Seq Age Sex Outcome Treatment
1 67 YR Required Intervention