MAUDE Adverse Event Report: ZOLL CIRCULATION, INC AUTOPULSE® RESUSCITATION SYSTEM MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

Complainant alleged that after a recent call it was observed that a male patient was bleeding from his chest.The injury was initially described as two puncture marks, which were located under the "puck" (electrodes) of the defibrillator pads.It was suggested that the patient's 5 year old cardiac surgery scar, had opened in two places.Manual cpr was performed for 6 minutes.No error codes were shown.No further information was provided.Please note that the event date is unknown.Manufacturer has made several attempts to obtain additional information, however no further information has been provided.

Manufacturer Narrative

Customer also reported that they saved the lifeband as well as the cpr stat pads from this incident.Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for analysis.Visual inspection of the returned platform shows no damages.A review of the autopulse archive was performed and no issues were observed on the reported event date.Functional testing was performed and the platform passed the initial system test.The load cell characterization was performed and it indicated that both load cells are functioning as intended.The platform was run with a 95% patient test fixture with known good batteries for several hours.No faults or errors were observed.Based on the investigation, no parts were identified for replacement.In summary, the platform was evaluated through functional testing and the platform passed all testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 3978129
• MDR Text Key: 21806135
• Report Number: 3003793491-2014-00382
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2014
• Initial Date FDA Received: 08/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/04/2014
• 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
• Treatment: MANUAL CPR; AUTOPULSE® LIFEBAND, CHEST COMPRESSION ASSEMBLY,; DEFIBRILLATION PADS
• Patient Outcome(s): Other