SPACELABS ADULT AMBULATORY BLOOD PRESSURE CUFF

Report

Report Number: 3010157426-2014-00064
Event Type: Injury
Date Received: October 9, 2014
Date of Event: September 9, 2014
Report Date: February 26, 2015
Manufacturer: SPACELABS HEALTHCARE INC.
Product Code: DXQ
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE PATIENT¿S SKIN CONDITION WAS SUCCESSFULLY TREATED WITH BIAFINE CREAM PRESCRIBED BY THE ATTENDING PHYSICIAN. ONSITE TESTING OF THE INVOLVED DEVICE BY A SPACELABS FIELD SERVICE ENGINEER CONFIRMED THAT THE EQUIPMENT PERFORMED TO SPECIFICATIONS. THE INVOLVED CUFF WAS SENT TO SPACELABS FOR FURTHER INVESTIGATION. ADDITIONAL INVESTIGATION OF THE CUFF WAS PERFORMED BY (B)(4) REGULATORY AGENCY FOR MEDICAL PRODUCT SAFETY) PER THEIR STANDARD. THE PATIENT DID NOT WEAR THE RECOMMENDED JERSEY CUFF PROTECTOR. THIS CUFF PROTECTOR ACTS AS AN INSULATOR AND PREVENTS ANY RESIDUAL CLEANING AGENT THAT MAY BE ON THE CUFF FROM IRRITATING SENSITIVE SKIN. THE (B)(4) REPORT CONCLUDED THAT RESIDUAL CLEANING AGENT ON THE CUFF WAS THE SOURCE OF THE REPORTED INJURY. THE CUSTOMER USES HEXANIOS FOR CLEANING THESE CUFFS. THE HEXANIOS SAFETY DATA SHEET LISTS SKIN IRRITATION AS A POSSIBLE HAZARD. SPACELABS¿ USER MANUAL DOES NOT LIST HEXANIOS AS A SPACELABS RECOMMENDED CLEANING AGENT. THERE WAS NO SPACELABS PRODUCT MALFUNCTION. THE CUSTOMER NOW ROUTINELY USES THE CUFF PROTECTOR TO PREVENT SKIN IRRITATION WHICH HAS RESOLVED THE ISSUE. THIS REPORT IS FINAL AND THE ISSUE IS CLOSED.

Additional Manufacturer Narrative · 1

THE PATIENT¿S SKIN CONDITION WAS SUCCESSFULLY TREATED WITH BIAFINE CREAM PRESCRIBED BY THE ATTENDING PHYSICIAN. ONSITE TESTING OF THE INVOLVED DEVICE BY A SPACELABS FIELD SERVICE ENGINEER CONFIRMED THAT THE EQUIPMENT PERFORMED TO SPECIFICATIONS. THE INVOLVED CUFF WAS SENT TO SPACELABS FOR FURTHER INVESTIGATION. ADDITIONAL INVESTIGATION OF THE CUFF WAS PERFORMED BY (B)(4) (B)(4) PER THEIR STANDARD. THE PATIENT DID NOT WEAR THE RECOMMENDED JERSEY CUFF PROTECTOR. THIS CUFF PROTECTOR ACTS AS AN INSULATOR AND PREVENTS ANY RESIDUAL CLEANING AGENT THAT MAY BE ON THE CUFF FROM IRRITATING SENSITIVE SKIN. THE (B)(4) REPORT CONCLUDED THAT RESIDUAL CLEANING AGENT ON THE CUFF WAS THE SOURCE OF THE REPORTED INJURY. THE CUSTOMER USES HEXANIOS FOR CLEANING THESE CUFFS. THE HEXANIOS SAFETY DATA SHEET LISTS SKIN IRRITATION AS A POSSIBLE HAZARD. SPACELABS¿ USER MANUAL DOES NOT LIST HEXANIOS AS A SPACELABS RECOMMENDED CLEANING AGENT. THERE WAS NO SPACELABS PRODUCT MALFUNCTION. THE CUSTOMER NOW ROUTINELY USES THE CUFF PROTECTOR TO PREVENT SKIN IRRITATION WHICH HAS RESOLVED THE ISSUE. THIS REPORT IS FINAL AND THE ISSUE IS CLOSED.

Additional Manufacturer Narrative · 1

CUSTOMER STATED THAT WHEN THE PATIENT RETURNED TO THE CARDIOLOGY DEPARTMENT ON (B)(6) FOR REMOVING THE (SPACELABS AMBULATORY BLOOD PRESSURE MONITOR), THEY FOUND THE PRESENCE OF A RASH ON THE PATIENT¿S ARM WITH THE MIRRORED INSCRIPTIONS OF THE CUFF LABELING (AMBULATORY BLOOD PRESSURE, ETC¿). A 24-32 CM CUFF (ADULT) WAS USED ON THE PATIENT. SPACELABS HAVE RECEIVED THE SAMPLE OF THE CUFF AND STARTED THE INVESTIGATION. ONSITE TESTING OF THE INVOLVED DEVICE BY A SPACELABS FIELD SERVICE ENGINEER CONFIRMED THAT THE EQUIPMENT WORKED TO SPECIFICATIONS. WE HAVE RECEIVED THE CUFF BIO-COMPATIBILITY REPORTS AND ALL WAS FINE. INVESTIGATION IS UNDERWAY. WE WILL FILE A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS CONCLUDED. PLACEHOLDER.

Description of Event or Problem · 1

SPACELABS RECEIVED A REPORT ON (B)(6) 2014 FROM A CUSTOMER IN (B)(6) THAT A PATIENT WEARING A SPACELABS ADULT AMBULATORY BLOOD PRESSURE CUFF MODEL 015-0068-04Q DEVELOPED A RED AND BROWN SKIN RASH WITH BURN MARKINGS AFTER PRODUCT USE. THIS WAS DISCOVERED BY THE CUSTOMER ON (B)(6) 2014 WHEN THE PATIENT ARRIVED AT THE FACILITY FOR REMOVAL OF THE CUFF WHICH WAS APPLIED ON (B)(6) 2014.

Description of Event or Problem · 1

SPACELABS RECEIVED A REPORT THAT A PATIENT ARM SHOWED SIGNS OF A SKIN RASH WITH BLISTERS AFTER USING A SPACELABS ADULT BLOOD PRESSURE CUFF.

Description of Event or Problem · 1

SPACELABS RECEIVED A REPORT ON SEPTEMBER 12, 2014 FROM A CUSTOMER IN (B)(6) THAT A PATIENT WEARING A SPACELABS ADULT AMBULATORY BLOOD PRESSURE CUFF MODEL 015-0068-04Q DEVELOPED A RED AND BROWN SKIN RASH WITH BURN MARKINGS AFTER PRODUCT USE. THIS WAS DISCOVERED BY THE CUSTOMER ON (B)(6) 2014 WHEN THE PATIENT ARRIVED AT THE FACILITY FOR REMOVAL OF THE CUFF WHICH WAS APPLIED ON (B)(6) 2014. THE ISSUE IS THE FOLLOWING: A PATIENT WORE AN ADULT ABP CUFF. WHEN REMOVED, THE NURSE DISCOVERED THE MIRRORED INSCRIPTIONS FROM THE CUFF ONTO THE ARM OF THE PATIENT. I SHOW THE "NORMAL" WRITING ON THE ABOVE RIGHT. YOU WILL ALSO NOTICE 2 BROWN AREAS: LIGHT BROWN JUST BELOW THE LAST LINE; DARKER BRAWN AREA AT THE BOTTOM; THESE AREAS LOOK LIKE THE SHAPE OF THE BLADDER (ROUNDED CORNERS). I HAVE BEEN INVESTIGATING A LITTLE BIT MORE WITH THE BIOMEDICAL ENGINEER WHO WAS SATISFIED WITH MY CALL. I WAS THINKING ABOUT AN ALLERGY WHICH DOESN'T SEEM TO BE THE CASE. THE BIOMED HAS BEEN ASKING THE NURSE ABOUT THE PRODUCT USED FOR DISINFECTION. THEY STATED THAT THEY HAVE BEEN USING THE SAME PROTOCOL FOR AGES. I HAVE NEVER SEEN SOMETHING LIKE THAT BEFORE. SO, I'M SENDING YOU THIS MESSAGE TO GET YOUR INPUT. FOR NOW, THE USER IS USING A PROTECTION TO AVOID THIS ISSUE. BUT WE CAN'T STAY LIKE THIS. WE SHOULD BE RECEIVING THE CUFFS (ADULT AND 1 BIGGER NEXT WEEK). THE DATE CODE GIVEN BY THE BIOMED FOR THE BLADDER IS 2014-03. PATIENT ARM WAS SHOWING ALL CHARACTERS FROM THE CUFF+ SHAPE OF THE BLADDER. PICTURE RECEIVED FROM CUSTOMER. THE CUFF WILL BE RECEIVED NEXT WEEK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
635995	SPACELABS ADULT AMBULATORY BLOOD PRESSURE CUFF	ADULT AMBULATORY BLOOD PRESSURE CUFF	DXQ	SPACELABS HEALTHCARE INC.		D 201403

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other