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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS ADULT NIBP AIRHOSE

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PHILIPS MEDICAL SYSTEMS PHILIPS ADULT NIBP AIRHOSE Back to Search Results
Model Number M1599B
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems High Blood Pressure/ Hypertension (1908); Injury (2348)
Event Date 08/15/2016
Event Type  Injury  
Manufacturer Narrative

It is unknown if emergent care/treatment was necessary. Therefore, this is being considered as a serious injury. At this time, there is indication of user error since it was reported that the philips nbp hose was modified to accept a third party (non-philips) cuff. As a result, we are considering this to be reportable. A follow up report will be submitted once the investigation is complete.

 
Event Description

The user reported elevated blood pressures readings (example 220/210). The readings were reported as atypical. It was also reported that a patient was injured due to the reported erroneous readings, but the extent of the patient's injuries is not known at this time. The user is reportedly "hesitant to provide more details. " initial investigation found that the philips nbp hose had been modified to accept a non-philips cuff.

 
Manufacturer Narrative

Field service engineer was dispatched to the customer site to evaluate the mms device, since the customer suspected this is what was causing the reported inaccurate nibp readings. The fse performed performance verification on the mms and the mms passed all testing. Additional information was obtained about the reported incident, which indicated that the customer modified the philips nibp hose to use critikon cuffs (critikon adult soft-cuff [ref]: sft-a2-2a -23-33 cm). The term modified was defined further to mean that the philips nibp hose¿s rectus connector was cut off and a critikon two-hose adaptor (for a two hose cuff) was put in its place. The customer stated that they believe this incident is possible a nursing error. The customer requested that philips provide documentation of the accessories that philips supports and what accessories they should be using. The customer reported elevated blood pressures readings. It was also reported that a patient was injured due to the reported erroneous readings, but the extent of the patient¿s injuries was not provided by the customer. The customer refused to release any patient information to philips including any vitals at the time of the event. The investigation determined that modification of the philips nibp hose by the customer in order to use critikon cuffs (non- philips-approved) may have contributed to the incident with the patient. We have no reason to believe an unmodified cuff would have contributed to this issue. Use of non-philips-approved accessories is contrary to the instructions for use (ifu). Accordingly, we are not considering this a device malfunction.

 
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Brand NamePHILIPS
Type of DeviceADULT NIBP AIRHOSE
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
richa shah
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key5945990
MDR Text Key54551219
Report Number1218950-2016-05627
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK090483
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/15/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/13/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM1599B
Device LOT NumberNOT PROVIDE
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/15/2016
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 TREATMENT DATA
Date Received: 09/13/2016 Patient Sequence Number: 1
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